NeVasc Aspiration System

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION November 10, 2025 Vesalio, Inc. Sharon Shachar Director of Regulatory and Clinical 2305 Historic Decatur Road Suite 100 San Diego, California 92106 Re: K251006 Trade/Device Name: NeVasc Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: October 8, 2025 Received: October 9, 2025 Dear Sharon Shachar: 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 &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251006 - Sharon Shachar 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 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- {2} K251006 - Sharon Shachar 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, Ph.D. 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} 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) K251006 | | | Device Name NeVasc Aspiration System | | | Indications for Use (Describe) NeVasc Aspiration Catheter: As part of the NeVasc Aspiration System, the NeVasc Aspiration Catheter with the Vesalio 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. Vesalio Aspiration Tubing Set: As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is indicated to connect the NeVasc Aspiration Catheter to a compatible aspiration pump. | | | 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} VESALIO # 510(k) SUMMARY # K251006 As required by 21 CFR 807.92 ## Submitter: Vesalio, Inc. 2305 Historic Decatur Road Suite 100 San Diego, CA 92106 United States ## Contact Person: Sharon Shachar Director of Regulatory &amp; Clinical Phone: (248) 697-6616 Email: sshachar@vesalio.com ## Date Prepared: November 6, 2025 ## Device: Proprietary Name: NeVasc Aspiration System Common/Usual Name: Percutaneous Catheter Classification Name: Catheter, Thrombus Retriever Regulatory Class: Class II Product Code: NRY Regulation Number: 21 CFR 870.1250 ## Predicate: Proprietary Name: Penumbra System (Reperfusion Catheter RED 72) Product Code: NRY 510(k) Number: K211654 {5} VESALIO ## Device Description: The NeVasc Aspiration System consists of 1) NeVasc Aspiration Catheter, 2) Peel Away Introducer Sheath and 3) Vesalio Aspiration Tubing Set. The NeVasc Aspiration Catheter is a single-lumen, reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Vesalio Aspiration Tubing Set. The catheter distal shaft has an external hydrophilic coating aimed at reducing friction during use. The distal end of the catheter shaft is radiopaque for fluoroscopic visualization, and the proximal end contains a luer hub that allows attachment of accessories for flushing and aspiration. The peel-away introducer sheath is provided in the package to facilitate the insertion of the NeVasc Aspiration Catheter’s distal tip into an appropriate vascular sheath. The Vesalio Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to a rotating hemostasis valve (RHV) or the female luer hub of the NeVasc Aspiration Catheter. The other end of the tubing consists of a hose fitting to enable connection with an aspiration pump. A flow switch is connected in line to provide vacuum control. The NeVasc Aspiration System is provided sterile, non-pyrogenic, and is intended for single use only. ## Intended Use/Indications For Use: NeVasc Aspiration Catheter: As part of the NeVasc Aspiration System, the NeVasc Aspiration Catheter with the Vesalio 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. Vesalio Aspiration Tubing Set: As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is indicated to connect the NeVasc Aspiration Catheter to a compatible aspiration pump. ## Indications for Use Comparison: The NeVasc Aspiration System has the same Intended Use as the predicate device and has a similar Indications for Use statement as the predicate. While the Penumbra System’s Indications for Use specify the use with the Penumbra Aspiration Pump, the subject device’s Indications for Use specify use with a compatible aspiration pump. {6} VESALIO # Technological Comparison: The NeVasc Aspiration System and the predicate device, Penumbra System with Reperfusion Catheter RED 72 (K211654), share the same fundamental technological characteristics, similar materials, fundamental design, and sterilization method. A comparison of the subject device with the predicate device is summarized in Table 1. Table 1: Comparison of Subject Device and the Predicate Device | Device Name | NeVasc Aspiration System (Subject Device) | Penumbra System (Reperfusion Catheter RED 72) (Predicate) | | --- | --- | --- | | 510(k) Number | K251006 | K211654 | | Company | Vesalio, Inc. | Penumbra, Inc. | | Classification | 21 CFR 870.1250: Percutaneous Catheter | 21 CFR 870.1250: Percutaneous Catheter | | Product Code | NRY: Catheter, Thrombus Retriever | NRY: Catheter, Thrombus Retriever | | Intended Use | Restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. | Restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. | | Indications for Use | NeVasc Aspiration Catheter: As part of the NeVasc Aspiration System, the NeVasc Aspiration Catheter with the Vesalio 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. Vesalio Aspiration Tubing Set: As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is indicated to connect the NeVasc Aspiration Catheter to a compatible aspiration pump. | Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators 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 intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment. Penumbra 3D Revascularization Device: AS part of the Penumbra System, the Penumbra 3D Revascularization Device 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Penumbra Aspiration Tubing: As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | | Product Feature Comparison of Subject Device to Predicate Devices | | | 3 {7} VESALIO | Materials | Stainless Steel, PTFE, Polyurethane, Pebax, Nylon 12, Tungsten, Platinum/Iridium | Stainless Steel, PTFE, Polyurethane, Polyether Block Amide, Nylon 12, Nitinol, Platinum/Iridium | | --- | --- | --- | | Length | 115cm, 125cm, 132cm, 140cm | 115cm, 120cm, 125cm, 127cm, 132 cm | | Tip configuration | Straight | Straight | | Min ID | 0.070” (1.78mm) | 0.072” (1.83mm) | | Max OD | 0.085” (2.16mm) | 0.085” (2.16mm) | | Coating | Hydrophilic coating | Hydrophilic coating | | Coating length | 50cm | 30cm | | Accessories | Peel Away Introducer Sheath | Peelable Sheath, Shaping Mandrel, RHV | | Aspiration Tubing | ID: 0.110” Length: 107” | ID: 0.110” Length: 112” | | Packaging Materials | Polyethylene, Tyvek, Paperboard. | Polyester/Polyethylene/ Tyvek, Polystyrene, SRS Paperboard | | Sterilization | Yes (Ethylene Oxide) | Yes (Ethylene Oxide) | ## Performance Data: ## Bench Testing: Bench testing was conducted after subjecting the test articles to simulated use conditions, environmental conditioning, and simulated distribution, in order to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate device. Performance specifications and test methods were based primarily on ISO 10555-1 standard and included the following: | Test | Test Method | Conclusions | | --- | --- | --- | | Visual Inspection | The device and packaging were visually inspected. | The device met the acceptance criteria. | | Dimensional Verification | Catheter dimensions were measured. | All dimensions met specified tolerances. | | Simulated Use Including Clot Retrieval | The catheter was delivered, deployed, and retracted per the instructions for use within a simulated neurovasculature model. Clot retrieval from various locations of the anatomical model was performed. | The device performs as intended under simulated use conditions. | | Dynamic Burst Pressure | The catheter was tested in clinically relevant conditions for resistance to dynamic burst pressure. | The device met the acceptance criteria. | | Air and Liquid Leakage | The catheter was evaluated for liquid and air leakage. | The device met the acceptance criteria. | | Static Burst Pressure | The catheter was tested in clinically relevant conditions for resistance to static pressure. | The device met acceptance criterion. | | Tensile Force | The catheter shaft was tested for peak tensile strength. | The device met the acceptance criteria. | | Kink Resistance | The catheter shaft was tested around clinically relevant bend radii. | The device met the acceptance criteria. | | Torque Strength | The proximal end of the catheter was rotated with the catheter tip constrained from movement. | The device met the acceptance criteria. | {8} ESALIO | Corrosion Resistance | The catheter tested for signs of corrosion. | The device met the acceptance criteria. | | --- | --- | --- | | Tip Buckle | The distal tip of the catheter was tested for buckling force. | The subject device tip buckling force is comparable to the predicate device. | | Particulate Evaluation and Coating Integrity | Particulates generated during simulated use and coating integrity before/after simulated use were tested. | The device is comparable to the predicate device. | | Lumen Collapse | Resistance of the catheter and aspiration tubing to lumen collapse were tested. | The device met the acceptance criteria. | | Pump Compatibility | Compatibility of the catheter and aspiration tubing with an aspiration pump was tested. | The device met the acceptance criteria. | Additionally, packaging testing and sterile barrier integrity validation were performed per ISO 11607-1 and ISO 11607-2. All results met their predefined acceptance criteria. ## Shelf Life Testing: Shelf life testing of samples aged and subjected to transportation simulation were performed and the results met predefined acceptance criteria. ## Sterilization: The NeVasc Aspiration System is Ethylene Oxide (EO) sterilized. The device is provided sterile for single use while demonstrating a sterility assurance level (SAL) of $10^{-6}$. The NeVasc Aspiration System meets the requirements for EO residuals per EN ISO 10993-7 for a limited contact delivery system – externally communicating. 5 {9} VESALIO ## Biocompatibility: The NeVasc Aspiration System was assessed for biocompatibility in accordance with ISO 10993-1 and FDA guidance document entitled, “Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process",” issued September 8, 2023. The NeVasc Aspiration Catheter is considered an external communicating device with direct contact with circulating blood for a limited (≤24 hours) duration of exposure. The Peel Away Introducer Sheath and the Vesalio Aspiration Tubing Set are considered external communicating devices with indirect blood contact (via the fluid path) for a limited (≤24 hours) duration of exposure. Based on this classification, tests relevant to the device components were selected and conducted in accordance with ISO 10993-1 and its applicable sub-parts. The NeVasc Aspiration System passed all biocompatibility testing. The results of the biocompatibility testing are summarized in the table below. | Test and Standard | Results | Conclusion | | --- | --- | --- | | Cytotoxicity (MEM Elution) | Non-cytotoxic | Pass | | Irritation (Intracutaneous Reactivity) | Non-irritant | Pass | | Sensitization (Guinea Pig Maximization) | Non-sensitizer | Pass | | Acute Systemic Toxicity (Injection study) | Non-toxic | Pass | | Systemic Toxicity (Material-Mediated Pyrogenicity) | Non-pyrogenic | Pass | | Direct and Indirect Hemolysis (ASTM F756) | Non-hemolytic | Pass | | SC5b-9 Complement Activation | Comparable results to historical negative controls and <5% of the Cobra Venom Factor positive control. | Pass | | Partial Thromboplastin Time Assay with Comparison Article | Materials do not significantly affect the coagulation system. | Pass | | Heparinized Blood Platelet and Leukocyte Count Assay | Materials do not significantly affect platelets. | Pass | | In Vitro Blood Loop Assay with Comparison Article | Non-thrombogenic | Pass | ## Animal Study: Non-clinical animal testing comparing the safety, usability, and performance of the NeVasc Aspiration System to the predicate was conducted in a swine model. Testing was performed in accordance to Good Laboratory Practice (GLP) regulations (21 CFR Part 58). Sub-acute (4-day) and chronic (28-day) timepoints were assessed. The study included aspiration of experimental soft and firm clots and simulated use assessments in vessels without clots. Device usability, radiopacity, and compatibility with ancillary devices were evaluated and found to be comparable between the test and control devices. Angiographic and histological evaluations demonstrated that the NeVasc Aspiration System was comparable to the predicate device at both timepoints. No vessel dissection, perforation, or device related thrombosis were observed. The {10} VESALIO results of the animal studies support the safety and performance of the NeVasc Aspiration System. ## Clinical: No clinical studies were conducted as bench testing and the animal study were determined sufficient for verification and validation purposes and to support substantial equivalence. ## Conclusion: The NeVasc Aspiration System is substantially equivalent to the predicate device, Penumbra System (K211654) based on the same intended use and similar indications for use, same or similar materials, similar design, and the same operating principles. The collective results of non-clinical performance testing demonstrated that the subject device meets all design specifications and performs as intended. The technological differences between the subject device and the predicate device do not raise new or different questions of safety or effectiveness. Therefore, it is concluded that the subject device is substantially equivalent to the predicate device. 7