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 |
|---|---|---|---|
| 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 |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | Stryker Neurovascular | 2025-03-21 |
| K243593 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2025-02-18 |
| K242051 | VersaD Delivery Catheter | Unity Medical, Inc. | 2025-01-17 |
| K243297 | APRO 70 Swift Catheter | Alembic, LLC | 2025-01-14 |
| K243577 | Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. | 2025-01-14 |
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2025-01-02 |
| K242376 | Next Generation Access Platform | Balt USA, LLC | 2024-12-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810068568059 | Carrier™ Delivery Catheter | BALT USA LLC | 2023-11-07 |
| 00810068561982 | Carrier™ Delivery Catheter | BALT USA LLC | 2023-11-07 |
| 00810068561944 | Carrier™ Delivery Catheter | BALT USA LLC | 2023-11-07 |
| 00815948026247 | Benchmark MAX System | PENUMBRA, INC. | 2023-06-27 |
| 00815948026216 | Benchmark MAX System | PENUMBRA, INC. | 2023-06-27 |
| 00815948026223 | Benchmark MAX System | PENUMBRA, INC. | 2023-06-27 |
| 00815948026230 | Benchmark MAX System | PENUMBRA, INC. | 2023-06-27 |
| 00812212030573 | Zoom 88 Large Distal Platform Support | IMPERATIVE CARE, INC. | 2023-06-02 |
| 00812212030566 | Zoom RDL Radial Access System, 103cm | IMPERATIVE CARE, INC. | 2022-09-28 |
| 00812212030535 | Zoom RDL Radial Access System, 110cm | IMPERATIVE CARE, INC. | 2022-09-28 |
| 00812212030528 | Zoom RDL Radial Access System, 105cm | IMPERATIVE CARE, INC. | 2022-09-28 |
| 00812212030511 | Zoom RDL Radial Access System, 95cm | IMPERATIVE CARE, INC. | 2022-09-28 |
| 00812212030399 | TracStar™ Large Distal Platform | IMPERATIVE CARE, INC. | 2022-08-11 |
| 00812212030405 | ZOOM™ 88 Large Distal Platform | IMPERATIVE CARE, INC. | 2022-08-11 |
| 00812212030467 | TracStar™ Large Distal Platform | IMPERATIVE CARE, INC. | 2022-08-11 |
| 00763000541194 | RistTM | Micro Therapeutics, Inc. | 2022-05-01 |
| 00763000541200 | RistTM | Micro Therapeutics, Inc. | 2022-05-01 |
| 00763000541217 | RistTM | Micro Therapeutics, Inc. | 2022-05-01 |
| 00812212030351 | ZOOM™ 88 Large Distal Platform | IMPERATIVE CARE, INC. | 2021-09-22 |
| 00812212030504 | ZOOM™ 88-T Large Distal Platform | IMPERATIVE CARE, INC. | 2021-09-22 |
| 00812212030368 | Zoom 88 Large Distal Platform | IMPERATIVE CARE, INC. | 2021-09-22 |
| 00812212030344 | TracStar LDP Large Distal Platform | IMPERATIVE CARE, INC. | 2021-09-22 |
| 00812212030337 | TracStar LDP Large Distal Platform | IMPERATIVE CARE, INC. | 2021-09-22 |
| 00763000413767 | Rist™ | Micro Therapeutics, Inc. | 2020-10-05 |
| 00763000413828 | Rist™ | Micro Therapeutics, Inc. | 2020-10-05 |
| 00763000413811 | Rist™ | Micro Therapeutics, Inc. | 2020-10-05 |
| 00763000413804 | Rist™ | Micro Therapeutics, Inc. | 2020-10-05 |
| 00763000413798 | Rist™ | Micro Therapeutics, Inc. | 2020-10-05 |
| 00763000413781 | Rist™ | Micro Therapeutics, Inc. | 2020-10-05 |
| 00763000413774 | Rist™ | Micro Therapeutics, Inc. | 2020-10-05 |