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 |
|---|---|---|---|
| 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 |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2025-06-20 |
| K251240 | Branchor X Balloon Guide Catheter | 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 |
| K243577 | Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. | 2025-01-14 |
| K243297 | APRO 70 Swift Catheter | Alembic, LLC | 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 |
| K241637 | Echo Intracranial Base Catheter | Stryker Neurovascular | 2024-12-19 |
| K241768 | Broadway 8 Catheter | Stryker Neurovascular | 2024-12-19 |
| K242033 | Access25™ Delivery Microcatheter | Penumbra, Inc. | 2024-12-11 |
| K240971 | 87 NeuGlide Catheter | Piraeus Medical | 2024-12-06 |
| K242301 | Socrates 38 Catheter | Scientia Vascular, Inc. | 2024-12-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886704088103 | CEREGLIDE | Cerenovus, Inc. | 2025-10-13 |
| 10886704088097 | CEREGLIDE | Cerenovus, Inc. | 2025-10-13 |
| 10886704088073 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704086611 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704086598 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704086550 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704086536 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704086437 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704086451 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704086499 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 10886704086475 | CEREGLIDE | Cerenovus, Inc. | 2025-09-26 |
| 07613327623352 | AXS Lift | Stryker Corporation | 2025-03-04 |
| 07613327623390 | AXS Lift | Stryker Corporation | 2025-03-04 |
| 10886704085409 | CEREGLIDE | Cerenovus, Inc. | 2023-07-07 |
| 10886704085423 | CEREGLIDE | Cerenovus, Inc. | 2023-07-07 |
| 10886704085584 | PROWLER | Medos International Sàrl | 2022-05-24 |
| 10886704085614 | PROWLER | Medos International Sàrl | 2022-05-24 |
| 10886704085607 | PROWLER | Medos International Sàrl | 2022-05-24 |
| 10886704085591 | PROWLER | Medos International Sàrl | 2022-05-24 |
| 07613327519372 | AXS VECTA 46 | Stryker Corporation | 2021-12-17 |
| 10886704084709 | PROWLER | Medos International Sàrl | 2021-09-28 |
| 10886704084693 | PROWLER | Medos International Sàrl | 2021-09-28 |
| 10886704084662 | PROWLER | Medos International Sàrl | 2021-09-28 |
| 07613327313956 | Trevo Trak 21 | Stryker Corporation | 2020-04-17 |
| 07613327459265 | AXS VECTA 74 | Stryker Corporation | 2019-02-19 |
| 07613327459258 | AXS VECTA 74 | Stryker Corporation | 2019-02-19 |
| 07613327459241 | AXS VECTA 74 | Stryker Corporation | 2019-02-19 |
| 07613327459234 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |
| 07613327459227 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |
| 07613327459210 | AXS VECTA 71 | Stryker Corporation | 2018-10-26 |