Product code QJP
- Device name
- Catheter, Percutaneous, Neurovasculature
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1250
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To provide vascular access to the neurovasculature for interventional or diagnostic procedures
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261649 | Excelsior Reach Microcatheter | Stryker Neurovascular | 2026-10-09 |
| K261938 | APRO 88 Catheter | Alembic, LLC | 2026-10-06 |
| K253422 | OAB Delivery Catheter | Cognition Medical Corp. | 2026-10-02 |
| K260220 | Route 92 Medical Full Length 046 Access System | Route 92 Medical, Inc. | 2026-09-16 |
| K262277 | 70 NeuGlide Catheter | Piraeus Medical, Inc. | 2026-09-04 |
| K261176 | Zoom 4S Catheter | Imperative Care, Inc. | 2026-08-28 |
| K254071 | p17 XR Microcatheter | Wallaby Medical | 2026-08-18 |
| K260199 | SLIM Microcatheter | Balt USA, LLC | 2026-07-13 |
| K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | 2026-07-09 |
| K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026-07-01 |
| K261808 | ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 |
| K261549 | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | 2026-06-09 |
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 |
| K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | 2026-05-11 |
| K254046 | BosCATH Support Catheter | Sonorous NV, Inc. | 2026-04-21 |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | 2026-04-16 |
| K260938 | PATH BGC | Crossroads Neurovascular, Inc. | 2026-04-15 |
| K253975 | Radical 6F Access Catheter | Maduro Medical, Inc. | 2026-04-09 |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2026-02-11 |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | 2026-01-16 |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 2026-01-06 |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | 2026-01-05 |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | 2025-12-03 |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc. | 2025-10-24 |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | 2025-10-22 |
| K250960 | DUO Microcatheter | Rev Neuro, LLC | 2025-09-08 |
| K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2025-06-20 |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2025-06-20 |
| K251044 | 93 NeuFlex Catheter | Piraeus Medical | 2025-05-23 |
| K242392 | PATH BGC | Crossroads Neurovascular, Inc. | 2025-05-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850085183002 | FreeClimb 46 Catheter x125cm | ROUTE 92 MEDICAL | 2026-10-12 |
| 00850085183019 | FreeClimb 46 Catheter x143cm | ROUTE 92 MEDICAL | 2026-10-12 |
| 00850085183026 | FreeClimb 46 Catheter x125cm with Tenzing 4 | ROUTE 92 MEDICAL | 2026-10-12 |
| 00850085183033 | FreeClimb 46 Catheter x143 cm with Tenzing 4 | ROUTE 92 MEDICAL | 2026-10-12 |
| 00850085183040 | Tenzing 4 Delivery Catheter | ROUTE 92 MEDICAL | 2026-10-12 |
| 00860015527738 | 70 NeuGlide Catheter | PIRAEUS MEDICAL INC. | 2026-10-06 |
| 00860015527745 | 70 NeuGlide Catheter | PIRAEUS MEDICAL INC. | 2026-10-06 |
| 00810068568998 | Next Generation 088 Catheter | BALT USA LLC | 2026-10-01 |
| 00840303713104 | Next Generation 088 Catheter | BALT USA LLC | 2026-10-01 |
| 00812212030788 | Zoom 4S Catheter | IMPERATIVE CARE, INC. | 2025-11-24 |
| 00812212030771 | Zoom 4S Catheter | IMPERATIVE CARE, INC. | 2025-11-24 |
| 00812212030764 | Zoom 4S Catheter | IMPERATIVE CARE, INC. | 2025-11-24 |
| 07613327623352 | AXS Lift | Stryker Corporation | 2025-03-04 |
| 07613327623338 | AXS Lift | Stryker Corporation | 2025-03-04 |
| 07613327623376 | AXS Lift | Stryker Corporation | 2025-03-04 |
| 07613327623390 | AXS Lift | Stryker Corporation | 2025-03-04 |
| 10886704082743 | EMBOGUARD | NEURAVI LIMITED | 2021-12-22 |
| 10886704082736 | EMBOGUARD | NEURAVI LIMITED | 2021-12-22 |
| 10886704028796 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028802 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028819 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028826 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028840 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028857 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028864 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028871 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028888 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028895 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028789 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |
| 10886704028772 | PROWLER SELECT | Medos International Sàrl | 2016-06-30 |