Who can help prepare an FDA 510(k) submission like Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)

Q: Who is the manufacturer of Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)?

Merit Medical Systems, Inc. filed the 510(k) submission for Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) (K240261).

Q: What is the FDA product code for Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)?

KRD. It is classified under 21 CFR 870.3300 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)?

510(k) clearance (submission type: Traditional).

K240261 · Merit Medical Systems, Inc. · KRD · May 2, 2024 · Cardiovascular

Device Facts

Record ID	K240261
Device Name	Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
Applicant	Merit Medical Systems, Inc.
Product Code	KRD · Cardiovascular
Decision Date	May 2, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3300
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Siege Vascular Plug is intended for therapeutic embolization to reduce or obstruct blood flow.

Device Story

Self-expanding braided Nitinol vascular embolization implant; used for therapeutic embolization to reduce or obstruct blood flow in peripheral vasculature. Device delivered via microcatheter (0.021" or 0.027" ID) under fluoroscopic guidance by physicians trained in endovascular techniques. System includes plug, delivery wire with hydrophilic coating, loader, torque device, and Tuohy Borst valve. Physician advances plug through microcatheter to target site; device self-expands to occlude vessel. If position unsatisfactory, device can be repositioned or removed; if satisfactory, delivery wire rotated counterclockwise via torque device to release plug. Radiopaque marker bands facilitate visualization. Benefits include controlled, precise vessel occlusion.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing (simulated use, tensile strength, fatigue, radial force, nickel leach, corrosion, radiopacity, particulate, sterilization, shelf life, biocompatibility) and a GLP-compliant porcine animal study evaluating acute/chronic safety, performance, and handling compared to a reference device.

Technological Characteristics

Self-expanding braided Nitinol plug with platinum-iridium radiopaque markers. Delivery wire features Nitinol core, stainless steel screw, gold-plated tungsten coil, and hydrophilic polymer jacket. Dimensions: 4.5mm, 6.5mm, 8.5mm diameters. Compatible with 0.021"/0.027" ID microcatheters. Sterilized via Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for arterial embolization in the peripheral vasculature.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

Siege Vascular Plug (K212817)

Reference Devices

Micro Vascular Plug System (MVP) (K123803, K133282, K150108)
Amplatzer Vascular Plug (AVP) (K031810)
Micro Plug Set (K182944)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. May 2, 2024 Merit Medical Systems, Inc. James Kenny Principal Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland # Re: K240261 Trade/Device Name: Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: January 31, 2024 Received: April 8, 2024 # Dear James Kenny: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Misti L. Malone -S Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240261 #### Device Name Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) Indications for Use (Describe) The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | | Submitter Name: Address: Telephone Number: Fax Number: Contact Person: Registration Number: | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 (+353) 91 651 560 (+353) 91 680 104 James Kenny 1721504 | |-----------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | General Provisions | Correspondent Name: Address: | Merit Medical Ireland Ltd. Parkmore Business Park Parkmore, Galway, Ireland | | | Telephone Number: Fax Number: | (+353) 91 703 761 (+353) 91 680 104 | | | Contact Person: | James Kenny | | | Date of Preparation: Registration Number: | 26 January 2024 9616662 | | Subject Device | Trade Name: Common/Usual Name: Class: Product code: Classification Name: | Siege™ Vascular Plug Vascular embolization plug II KRD Device, Vascular, For Promoting Embolization | | | Regulation Number: Regulation Medical Specialty | 21 CFR 870.3300 Cardiovascular | | | Trade Name: | Siege™ Vascular Plug | | | Class: Product code: | II KRD | | Predicate Device | Classification Name: | Device, Vascular, For Promoting Embolization | | | Regulation Number: Regulation Medical Specialty | 21 CFR 870.3300 Cardiovascular | | | Premarket Notification: | K212817 | | | Manufacturer: | Merit Medical Systems, Inc. | {4}------------------------------------------------ | | Reference Device#1: Trade Names: Premarket Notification: | Micro Vascular Plug System (MVP) MVP-3Q, MVP-5Q, MVP-7Q K123803, K133282, K150108 | |----------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Reference Devices | Reference Device#2: Trade Name: Premarket Notification: | Amplatzer Vascular Plug (AVP) K031810 | | | Reference Device#3: Trade Name: Premarket Notification: | Micro Plug Set K182944 | The subject Siege Vascular Plug ("Device") is a self-expanding braided Nitinol vascular embolization implant that is supplied with components used for implantation. The Device has radiopaque marker bands attached to each end and a screw attachment for connection to the Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 225 cm Delivery Wire that is provided within a hoop dispenser. The Delivery Wire has a lubricious, hydrophilic coating at its distal end (approximately 26.5cm long). A Tuohy Borst Valve is provided for flushing and maintaining hemostasis: a Torque Device is provided for releasing the Device; a Non-Vented Luer Cap is provided for device preparation. ### Device The subject Siege Vascular Plug has been designed with a material, Description size, configuration, and shape that allows introduction through recommended 0.021" or 0.027" inner diameter commercial microcatheters for the embolization of arterial blood vessels in the peripheral vasculature. The Siege Vascular Plug Devices are provided in three different outer diameters (4.5 mm, 6.5 mm, 8.5 mm) to treat different artery diameter ranges (1.5 - 2.5 mm, 2.5 - 4 mm, 4 - 6 mm) in the peripheral vasculature. > The subject Siege Vascular Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature. The main users are physicians trained in standard endovascular techniques. | Intended Use | The Siege Vascular Plug is intended for therapeutic embolization to reduce or obstruct blood flow. | |---------------------|-------------------------------------------------------------------------------------------------------| | Indications for Use | The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature. | {5}------------------------------------------------ The subject Siege Vascular Plug is substantially equivalent in its intended use/indications for use, technology/principle of operation, materials, and performance specification to the predicate Siege Vascular Plug [K212817]. A comparison of the technological characteristics is summarized in the table below: | | Device Characteristic | Subject Siege Vascular Plug | Predicate Siege Vascular Plug | |-----------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) # | | To be assigned | K212817 | | Product Code | | KRD | KRD | | Intended Use/ Indications for Use | | The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature. The Siege Vascular Plug is intended for therapeutic embolization to reduce or obstruct blood flow. | Indicated for arterial embolization in the peripheral vasculature. | | Comparison to Predicate | Components Supplied in the Sterile Package | Siege Vascular Plug Loader Delivery Wire Torque Device Tuohy Borst Valve Non-Vented Luer Cap | Siege Vascular Plug Loader Delivery Wire Torque Device Tuohy Borst Valves (2) | | | Component Construction Materials | Plug Nitinol braid Platinum-Iridium radiopaque marker bands Platinum-Iridium female threaded component at proximal end | Plug Nitinol braid Platinum-iridium radiopaque marker bands 316 L Stainless Steel female threaded component at proximal end | | | | Delivery Wire Nitinol ground core wire, stainless steel screw, gold plated tungsten coil, polymer (Pellethane) jacket with a lubricious, hydrophilic, coating applied at its distal end (26.5 +/- 1.5 cm long) | Delivery Wire Nitinol ground core wire, stainless steel screw, stainless steel outer coil. No lubricious coating. | {6}------------------------------------------------ K240261 Page 4 of 7 Tuohy Borst Valve Tuohy Borst Valve • Body, Housing, Nut and • Body and Cap – Cap – polycarbonate polycarbonate · Seal - silicone rubber, · Seal - silicone, blue • Washer - PTFE • O-ring – silicone rubber • Washer & Back-Up Ring | • Lubricant - Silicone Oil | | |------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Loader • High Density Polyethylene (HDPE) tubing with polyolefin heat shrink | Loader • Rilsan (nylon) tubing with Vestamid hub and PTFE liner | | Torque Device • Polycarbonate cap, polypropylene body, brass collet | Torque Device • Polycarbonate cap, polypropylene body, brass collet | | Non-Vented Luer Cap • Polycarbonate • Colorant, Polycarbonate, Red | | | Siege Vascular Plug | Siege Vascular Plug | | Diameter sizes: 4.5, 6.5, & | Diameter sizes: 3,4,5 & 6 | | Dimensions | Siege Vascular Plug | Siege Vascular Plug | | | | | | | | | | | | | | | | | | | |------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--| | | Diameter sizes: 4.5, 6.5, & 8.5 mm | Diameter sizes: 3,4,5 & 6 mm | | | | | | | | | | | | | | | | | | | | | Construction: | Construction: | | | | | | | | | | | | | | | | | | | | | 2 lobes 2 or 3 braid layers - each layer is comprised of 64 and/or 72 wires with diameters of 0.0008 and/or 0.001 inches Female threaded bushing with either 0.065 or 0.080" length Markerband ID 0.016" Device Diameter Device Length* 4.5 mm 6.4 mm 6.5 mm 7.3 mm 8.5 mm 7.8 mm *unconstrained – elongates when constrained with oversizing | | | | | | | | | 3 lobes 2 braid layers - each layer is comprised of 72 wires with diameters of 0.0008 and/or 0.001 inches Female threaded bushing 0.052" length Markerband ID 0.016" Device Diameter Device Length* 3 mm 6.0 mm 4 mm 5.2 mm 5 mm 5.2 mm 6 mm 5.2 mm *unconstrained - elongates when constrained with oversizing | | | | | | | | | | | | | Delivery Wire Outer Diameter: 0.022" and 0.018" Length: 225 cm | Delivery Wire Outer Diameter: 0.022" Length: 180 cm | | | | | | | | | | | | | | | | | | | blue – PTFE • Adhesive {7}------------------------------------------------ | | Loader • Inner Diameter: 0.023" & 0.028" • Length: 14" Touhy Valve • FLO50 Torque Device • 3 Part torque device | Loader • Inner Diameter: 0.026" ID • Length: 11.2" Touhy Valve • FLO40 Torque Device • 3 Part torque device | | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Catheter Compatibility | Delivery Catheter (not included) Introduction through 0.021" or 0.027" inner diameter commercially compatible microcatheters up to 175 cm long is recommended. | Delivery Catheter (not included) Introduction through 0.027" inner diameter commercially compatible microcatheters up to 150 cm long is recommended. | | | Use | Single Use | Single Use | | | Anatomical Site | Peripheral vasculature | Peripheral vasculature | | | Sterilization | Sterile/Ethylene Oxide SAL 10-6 | Sterile/Ethylene Oxide SAL 10-6 | | | Shelf Life | 6-months | 3-years | | | Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | | | Packaging | Pouch and generally square box designed to accommodate all components (except a microcatheter). Accessory pouch for torque device, Tuohy Borst Valve and non- vented luer cap. Hoop dispenser to contain delivery wire, loader and plug with a retention clip to anchor the delivery wire. | Length of backing card, pouch and box designed to accommodate all components (except a microcatheter). Similar packaging but will be shorter in length to accommodate the removal of the catheter and will include a retention clip to anchor the delivery wire. | | | Principles of operation | The Delivery Wire with attached Siege Vascular Plug is transferred into a recommended 0.021" or 0.027" inner diameter commercially compatible microcatheter using the provided Loader. The Plug is advanced through a recommended microcatheter to the targeted position. The Siege Vascular Plug is advanced out of the microcatheter; the Siege Vascular Plug device self- expands recovering its pre- set shape and cross- | The Delivery Wire with attached Siege Vascular Plug is transferred into a recommended 0.027" inner diameter commercially compatible microcatheter using the provided Loader. The Plug is advanced through a recommended microcatheter to the targeted position. The Siege Vascular Plug is advanced out of the microcatheter; the Siege Vascular Plug device self- expands recovering its pre- set shape and cross- sectionally occludes the vasculature. If Device | | | | vasculature. If Device position is unsatisfactory, the device can be repositioned or removed. If position is satisfactory, the Delivery Wire is rotated counterclockwise using the provided Torque Device to release the Siege Vascular Plug. | position is unsatisfactory, the device can be repositioned or removed. If position is satisfactory, the Delivery Wire is rotated counterclockwise using the provided Torque Device to release the Siege Vascular Plug. | | {8}------------------------------------------------ No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. However, Vascular and Neurovascular Embolization Devices are subject to the Special Controls specified in "Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document for Industry and FDA Staff", issued in December 2004. A battery of testing was conducted, on the subject Siege Vascular Plug, in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence. The included performance testing, biocompatibility, evaluations sterilization, and animal studies. Where appropriate, the tests were based on the requirements of the following documents: ## Safetv & Performance Tests The following is a list of all testing that was successfully completed on the subject Siege Vascular Pluq: # Performance Non-Clinical Testing - 1. Simulated Use - 2. Set (Tensile) Strength - 3. Loader Heat Shrink Tensile - 4. Fatigue Testing - 5. Nickel Leach - 6. Radial Force - 7. Nitinol Austenite Finish Temperature - 8. MRI Compatibility - 9. Corrosion Testing - 10. Dimensional Testing/Size Designation - 11. Particulate Testing - 12. Radiopacity Testing - 13. Packaging - 14. Sterilization {9}------------------------------------------------ 15. Pyrogenicity 16. Shelf life 17. Biocompatibility 18. GLP Animal Study The GLP animal study was conducted to evaluate the acute and chronic safety, performance and handling of the subject Siege Vascular Plug as compared to a commercially available Reference Device in the peripheral arteries of a porcine model. Clinical testing was not required for the determination of substantial equivalence. All test results were comparable to the predicate Siege Vascular Plug and the subject Siege Vascular Plug met the predeterminded acceptance criteria. This demonstrated that the subject Siege Vascular Plug is substantially equivalent to the predicate Siege Vascular Plug. | Summary of Substantial Equivalence | Based on the comparisons noted, the subject Siege Vascular Plug meets the requirements for its intended use and is substantively equivalent to the predicate Siege Vascular Plug [K212817] also manufactured by Merit Medical Systems, Inc. | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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