InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 21, 2026 Merit Medical Ireland Ltd., Shane Costello Principal Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland Re: K251385 Trade/Device Name: InQwire Super Stiff Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 2, 2025 Received: May 5, 2025 Dear Shane Costello: 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251385 - Shane Costello Page 2 (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). 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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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-reporting-combination-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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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). {2} K251385 - Shane Costello Page 3 Sincerely, Jenny R. Katsnelson -S Digitally signed by Jenny R. Katsnelson -S Date: 2026.01.21 23:13:14 -05'00' for Lydia Glaw 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 Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251385 | | | Device Name InQwire Super Stiff Guide Wire | | | Indications for Use (Describe) The InQwire Super Stiff Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures. The InQwire Super Stiff Guide Wire is indicated for use in the peripheral vasculature and chambers of the heart, excluding the coronary arteries and cerebral vasculature. | | | Type of Use (Select one or both, as applicable) ☑ 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." | | {4} Page 1 of 4 K251385 Traditional 510(k) | 510(k) Summary | | | | --- | --- | --- | | General Provisions | Submitter Name: | Merit Medical Systems, Inc. | | | Address: | 1600 West Merit Parkway South Jordan, UT 84095 | | | Telephone Number: | (+353) 91 703700 | | | Fax Number: | (+353) 91 680104 | | | Contact Person: | Shane Costello | | | Registration Number: | 1721504 | | | Correspondent Name: | Merit Medical Ireland Ltd. | | | Address: | Parkmore Business Park Parkmore, Galway, Ireland | | | Telephone Number: | (+353) 91 703700 | | | Fax Number: | (+353) 91 680104 | | | Contact Person: | Shane Costello | | | Date of Preparation: | 02^{nd} May 2025 | | Registration Number: | 9616662 | | | Subject Device | Trade Name: | InQwire Super Stiff Guide Wire | | | Common/Usual Name: | Guide Wire | | | Class: | II | | | Product code: | DQX | | | Classification Name: | Wire, Guide, Catheter | | | Regulation Number: | 21 CFR 870.1330 | | | Regulation Medical Specialty | Cardiovascular | | Predicate Device | Trade Name: | PTFE Guide Wire | | | Class: | II | | | Product code: | DQX | | | Classification Name: | Wire, Guide, Catheter | | | Regulation Number: | 21 CFR 870.1330 | | | Regulation Medical Specialty | Cardiovascular | | | Premarket Notification: | K242824 | | | Manufacturer: | Lake Region Medical | Page 1 of 4 {5} Page 2 of 4 K251385 Traditional 510(k) # 510(k) Summary | Device Description | The Merit InQwire Super Stiff guide wire consists of 0.032" and 0.035" outer diameter (OD) guidewire configurations with guidewire lengths of 80cm, 100cm, 150cm, 180cm and 260cm. The guidewire is provided in straight and J3mm with a range of flexible properties. The Merit InQwire Super Stiff guide wire is composed of a stainless-steel core wire and a PTFE coated stainless steel coil. The guidewire is welded at the distal and proximal tip with each tip having a polished weld finish. The stainless-steel construction provides radiopacity. The guidewire is supplied sterile, non-pyrogenic and is intended for single patient use only. The Merit InQwire Super Stiff guide wire is placed through a vascular access device and advanced under fluoroscopy to the desired location according to the planned procedure by the clinician. It is used to facilitate the placement of devices during diagnostic and interventional procedures within the peripheral vasculature and central circulatory system, excluding the coronary arteries and cerebral vasculature. | | --- | --- | | Indications for Use | The InQwire Superstiff Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures. The InQwire Superstiff Guide Wire is indicated for use in the peripheral vasculature and chambers of the heart, excluding the coronary arteries and cerebral vasculature. | Page 2 of 4 {6} Page 3 of 4 K251385 Traditional 510(k) # 510(k) Summary ## Comparison to Predicate The technological characteristics of the subject InQwire Super Stiff Guide Wire are substantially equivalent to those of the predicate PTFE Guide Wire [K242824]. Both the subject guide wire and predicate guide wire consist of a stainless-steel coil wire and core wire. A polytetrafluoroethylene (PTFE) coating is applied over the guide wire. The subject guide wire and predicate guide wire have different dimensional specifications that do not impact the substantial equivalence. The fundamental technology and operating principles of the subject guide wire and the predicate guide wire are the same. The intended use for the subject and predicate devices is deemed to be equivalent. ## Safety & Performance Tests No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. Testing was conducted on the subject InQwire Super Stiff Guide Wire 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. Where appropriate, the tests were based on the requirements of the following documents: - FDA Guidance - "Coronary, Peripheral, and Neurovascular Guidewires Performance Tests and Recommended Labelling" – October 2019 - FDA Guidance - "Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations" – October 2019 - FDA Guidance - "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" – January 2016 - FDA Guidance - "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" – September 2020 - ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process Page 3 of 4 {7} Page 4 of 4 K251385 Traditional 510(k) # 510(k) Summary - TIR28:2016, Product adoption and process equivalence for ethylene oxide sterilization The following is a list of all testing that was successfully completed: ## Performance Non-Clinical Testing-Bench - Dimensional Verification - Guide Wire Diameters - Dimensional Verification - Guide Wire Length - Dimensional Verification - Distal Tip Configurations - Catheter & Needle Compatibility - Core Wire Profile - Coil Stretch - Tip Flexibility - Surface Finish - Radiopacity - Tip Pull Tensile Strength - Torque Strength - Coating Integrity - Particulate Evaluation - Lubricity - Corrosion Resistance - Kink Resistance - Fracture Test - Flexing Test - Design Validation Testing - Biocompatibility Testing Test results were compared to the predicate PTFE Guide Wire and the subject InQwire Super Stiff Guide Wire met the predetermined acceptance criteria. This demonstrated that the subject device is substantially equivalent to the predicate device. ## Summary of Substantial Equivalence Based on the comparisons noted, the subject InQwire Super Stiff Guide Wire meets the requirements that are considered essential for its intended use and is substantively equivalent to the Predicate Device, the PTFE Guide Wire [K242824].