CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set

{0} **U.S. FOOD & DRUG** ADMINISTRATION August 13, 2026 Cerenovus, Inc. Mia Dudicova Regulatory Affairs Contractor 6303 Waterford District Drive, Suite 315 Miami, Florida 33126 Re: K262398 Trade/Device Name: CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY, QJP Dated: July 12, 2026 Received: July 15, 2026 Dear Mia Dudicova: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262398 – Mia Dudicova Page 2 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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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- {2} K262398 – Mia Dudicova Page 3 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, NAIRA MURADYAN -S Naira Muradyan, PhD Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262398 | ? | | Please provide the device trade name(s). | | ? | | CEREGLIDE™ 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | | | | Please provide your Indications for Use below. | | ? | | Product Code NRY: The CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. Product Code QJP: The CEREGLIDE 57 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} Cerenovus, Inc. Special 510(k) Premarket Notification CEREGLIDE™ 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set # 510(k) Summary – K262398 ## I. Submitter Cerenovus, Inc. 6303 Waterford District Drive, Suite 315 Miami, FL 33126 USA Contact Person: Mia Dudicova (Regulatory Affairs Contractor) Email: MDudicov@its.jnj.com Tel: 00353 87 466 0113 ## II. Date ## Prepared July 12 \( ^{th} \) , 2026 ## III. Device ## Information | Table 1. Device Information | | | --- | --- | | Device Proprietary Name | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | | Common or Usual name | Catheter, Thrombus Retriever Catheter, Percutaneous | | Classification Name | 21 CFR 870.1250 – Catheter, Thrombus Retriever 21 CFR 870.1250 – Catheter, Percutaneous | | Regulatory Classification | II | | FDA Product Codes | NRY, QJP | ## IV. Predicate ## Device ## Information The predicates are listed below in Table 2. | Table 2. Predicate Devices | | | | | --- | --- | --- | --- | | 510(k) Number | Date Cleared | Name | Manufacturer | | K241221 | October 16, 2024 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | | K241244 | October 16, 2024 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | Cerenovus, Inc. | Continued on the next page Page 1 of 6 {5} Cerenovus, Inc. Special 510(k) Premarket Notification CEREGLIDE™ 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set # 510(k) Summary, continued # V. Device Description The CEREGLIDE™ 57 Intermediate Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless-steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless-steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter. The CEREGLIDE™ 57 Intermediate Catheter is designed for use in facilitating the insertion and guidance of appropriately sized interventional devices and as conduit for retrieval devices, and in the removal of thrombus from the neurovasculature using continuous aspiration from an external vacuum source when used with the Cerenovus Aspiration Tubing Set. The CEREGLIDE™ 57 Intermediate Catheter and Cerenovus Aspiration Tubing Set are intended to be used with a compatible aspiration pump as a vacuum source that provides a minimum vacuum pressure of -68 kPa [-20 inHg] and a maximum vacuum pressure of -95 kPa [-28 inHg], and minimum 17 L/min flow rate, with a collection canister of at least 1000 mL volume. The CEREGLIDE™ 57 Intermediate Catheter is intended to be connected to the vacuum source using the Cerenovus Aspiration Tubing Set which is an externally manufactured tubing set with an internal diameter (ID) of 0.110" and overall length of 112", containing an integrated flow control switch. # VI. Indications for Use # Product code NRY: The CEREGLIDE™ 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. # Product code QJP: The CEREGLIDE™ 57 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE™ 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices. Page 2 of 6 {6} Cerenovus, Inc. Special 510(k) Premarket Notification CEREGLIDE™ 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set ### VII. Predicate Comparison A comparison of product features between CEREGLIDE™ 57 Intermediate Catheter and Cerenovus Aspiration Tubing Set and the predicate devices is presented in Table 3. Continued on next page Page 3 of 6 {7} Cerenovus, Inc. Special 510(k) Premarket Notification CEREGLIDE™ 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set ## 510(k) Summary, continued | Table 3. Predicate and Subject Device Comparison | | | | | | --- | --- | --- | --- | --- | | Description | Predicate Device: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K241221, NRY) | Predicate Device: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (K241244, QJP) | Subject Device: CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (NRY) | Subject Device: CEREGLIDE 57 Intermediate Catheter (QJP) | | Indications For Use | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71,57 or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter are indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | The CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71,57 or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. | The CEREGLIDE 57 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | | Product Code | NRY | QJP | NRY | QJP | | Regulation Name | Catheter, Thrombus Retriever | Catheter, Percutaneous | Catheter, Thrombus Retriever | Catheter, Percutaneous | | Classification | Class II - 21 CFR 870.1250 | | Same as predicates | | | Basic Design | Variable stiffness single lumen catheter | | Same as predicates | | Page 4 of 6 {8} Cerenovus, Inc. Special 510(k) Premarket Notification CEREGLIDE™ 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Table 3 Predicate and Subject Device Comparison | | | | | | --- | --- | --- | --- | --- | | Description | Predicate Device: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K241221, NRY) | Predicate Device: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (K241244,QJP) | Subject Device: CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set (NRY) | Subject Device: CEREGLIDE 57 Intermediate Catheter (QJP) | | Length | CEREGLIDE 42: 115 cm, 125 cm, 132 cm, 144 cm, 152 cm, 160 cm | | CEREGLIDE 57: 115 cm, 125 cm, 132 cm, 137 cm, 152 cm | | | | CEREGLIDE 57: 115 cm, 125 cm, 132 cm, 137 cm | | | | | Inner Diameter (ID) | CEREGLIDE 42: 0.042" CEREGLIDE 57: 0.057" | | 0.057" | | | Distal Outer Diameter (OD) | CEREGLIDE 42: 0.053" CEREGLIDE 57: 0.068" | | 0.068" | | | Proximal OD | CEREGLIDE 42: 0.0535" CEREGLIDE 57: 0.0685" | | 0.0685" | | | Catheter Coating | Hydrophilic | | Same as predicates | | | Coating Length | 55 cm | | Same as predicates | | | Tip Configuration | Non-shapeable tip | | Same as predicates | | | Marker Band | Platinum/ Iridium | | Same as predicates | | | Braid | Stainless Steel | | Same as predicates | | | Liner | PTFE Liner | | Same as predicates | | | Hub | Polycarbonate | | Same as predicates | | | Strain Relief | Polyolefin | | Same as predicates | | | Outer Jacket | Pebax, Urethane | | Same as predicates | | | Hemostasis Valve | Included | | Same as predicates | | | Introducer Sheath | Slit Introducer (2) | | Same as predicates | | | Sterilization Method | Ethylene Oxide | | Same as predicates | | | Sterility Assurance Level (SAL) | \( 10^{-6} \) | | Same as predicates | | | Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | | Same as predicates | | | Shelf Life | 3 years | | Same as predicates | | | | Predicate device (NRY) | | Subject Device (NRY) | | | Required Additional Accessories | Cerenovus Aspiration Tubing Set Compatible Aspiration Pump | | Same as predicate | | | Minimum Aspiration Pressure | -20 inHg (-68 kPa) | | Same as predicate | | | Maximum Aspiration Pressure | -28 inHg (-95 kPa) | | Same as predicate | | | Flowrate (Air) | 0 to 60 LPM | | Same as predicate | | | Tubing ID | 0.110 in minimum | | Same as predicate | | | Tubing Length | 112 in | | Same as predicate | | | Flow Control Mechanism | Flow Control Switch | | Same as predicate | | Continued on next page Page 5 of 6 {9} Cerenovus, Inc. Special 510(k) Premarket Notification CEREGLIDE™ 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set ## 510(k) Summary, continued VIII. Non-Clinical Performance Data **Performance Testing – Bench** No additional bench testing was required for the addition of 152 cm working length CEREGLIDE 57 Intermediate Catheter, as previously generated performance testing for predicate devices was deemed sufficient and appropriate for substantial equivalence determination. **Performance Testing – Animal** No animal study was deemed necessary to evaluate the changes to the subject device and demonstrate substantial equivalence to the predicate devices. **Performance Testing – Clinical** Clinical studies were not required as appropriate verification and validation of the design were achieved based on the similarities of the proposed device and the predicate devices, and previous non-clinical testing. **Sterilization** No additional sterilization cycle validation was deemed necessary to adopt the subject 152 cm working length model into the existing EO sterilization cycle. **Shelf-Life** Changes did not impact the established shelf-life of the product. **Biocompatibility Testing** Evaluation of the device change compared to the predicates showed the biological risk of the subject device is unchanged compared to the predicates. IX. Conclusion Based upon the intended use, design, materials, function, and previous non-clinical testing, it is concluded that the subject CEREGLIDE™ 57 Intermediate Catheter and Cerenovus Aspiration Tubing Set are substantially equivalent to the predicate devices CEREGLIDE™ 42 Intermediate Catheter, CEREGLIDE™ 57 Intermediate Catheter, and Cerenovus Aspiration Tubing Set (K241221) and CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter (K241244). The difference in length does not raise any new questions regarding the safety and effectiveness of the subject device. The subject device, as designed, manufactured, packaged, and sterilized, is substantially equivalent to the predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. End of document Page 6 of 6