QJP
- Product code
- QJP
- Device name
- Catheter, Percutaneous, Neurovasculature
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1250
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 58
- Summaries archived here
- 53 (direct download)
- 510(k) clearances (all years, FDA)
- 98 (all years; only the last 3 years are listed here)
FDA classification definition
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
510(k) clearances, last 3 years (58)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261176 | 2026-08-28 | Imperative Care, Inc. | Zoom 4S Catheter | |
| K254071 | 2026-08-18 | Wallaby Medical | p17 XR Microcatheter | |
| K260199 | 2026-07-13 | Balt USA, LLC | SLIM Microcatheter | |
| K253901 | 2026-07-09 | Perfuze, Ltd. | Millipede88 Access Catheter | |
| K261889 | 2026-07-01 | Stryker Neurovascular | Trevo Trak 21 Microcatheter | |
| K261808 | 2026-06-30 | Microvention Inc. d/b/a Terumo Neuro | ISAAC Neurovascular Navigation Catheter | |
| K261549 | 2026-06-09 | MicroVention, Inc., d/b/a Terumo Neuro | BOBBY Balloon Guide Catheter | |
| K253359 | 2026-05-22 | Suzhou Zenith Vascular SciTech Limited | Zenith Distal Access Long Sheath | |
| K254178 | 2026-05-11 | Asahi Intecc Co., Ltd. | SAYA 86 Radial Access Guide Catheter | |
| K254046 | 2026-04-21 | Sonorous NV, Inc. | BosCATH Support Catheter | |
| K254223 | 2026-04-16 | Balt USA, LLC | Next Generation 088 Catheter | |
| K260938 | 2026-04-15 | Crossroads Neurovascular, Inc. | PATH BGC | |
| K253975 | 2026-04-09 | Maduro Medical, Inc. | Radical 6F Access Catheter | |
| K253032 | 2026-02-11 | Stryker Neurovascular | AXS Lift Intracranial Base Catheter | |
| K252297 | 2026-01-16 | Toro Neurovascular, Inc. | Toro 88 Superbore Catheter | |
| K251097 | 2026-01-06 | Vesalio, Inc. | V-DAC Catheter | |
| K251668 | 2026-01-05 | Kaneka Americas Holding, Inc. | SurfRider 13 Microcatheter | |
| K252213 | 2025-12-03 | Bend IT Technologies, Ltd. | Bendit17 Microcatheter | |
| K251372 | 2025-10-24 | Unity Medical, Inc. | VersaD Delivery Catheter | |
| K252569 | 2025-10-22 | Balt USA, LLC | Carrier XL Delivery Catheter | FDA |
| K250960 | 2025-09-08 | Rev Neuro, LLC | DUO Microcatheter | |
| K251560 | 2025-06-20 | Asahi Intecc Co., Ltd. | FUBUKI XF-R Neurovascular Long Sheath | |
| K251240 | 2025-06-20 | Asahi Intecc Co., Ltd. | Branchor X Balloon Guide Catheter | |
| K251044 | 2025-05-23 | Piraeus Medical | 93 NeuFlex Catheter | |
| K242392 | 2025-05-09 | Crossroads Neurovascular, Inc. | PATH BGC | FDA |
| K242289 | 2025-03-21 | Stryker Neurovascular | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex … | |
| K243593 | 2025-02-18 | Stryker Neurovascular | AXS Lift Intracranial Base Catheter | |
| K242051 | 2025-01-17 | Unity Medical, Inc. | VersaD Delivery Catheter | |
| K243297 | 2025-01-14 | Alembic, LLC | APRO 70 Swift Catheter | |
| K243577 | 2025-01-14 | Maduro Medical, Inc. | Radical the Dude 8F Guide Catheter | |
| K241388 | 2025-01-02 | Micro Therapeutics, Inc. d/b/a ev3 Neu… | Rist 079 Radial Access Guide Catheter; Rist 071 Radi… | |
| K242376 | 2024-12-30 | Balt USA, LLC | Next Generation Access Platform | FDA |
| K241637 | 2024-12-19 | Stryker Neurovascular | Echo Intracranial Base Catheter | |
| K241768 | 2024-12-19 | Stryker Neurovascular | Broadway 8 Catheter | |
| K242033 | 2024-12-11 | Penumbra, Inc. | Access25 Delivery Microcatheter | |
| K240971 | 2024-12-06 | Piraeus Medical | 87 NeuGlide Catheter | |
| K242301 | 2024-12-04 | Scientia Vascular, Inc. | Socrates 38 Catheter | |
| K240746 | 2024-11-20 | Q'Apel Medical, Inc. | Neurovascular Access System Family | |
| K240711 | 2024-10-17 | Perfuze, Ltd. | Zipline Access Catheter | |
| K241244 | 2024-10-16 | Cerenovus, Inc. | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Int… | |
| K240529 | 2024-10-02 | Route 92 Medical, Inc. | 8F Modified Sheath System | |
| K234074 | 2024-07-02 | Balt USA, LLC | Next Generation Access Catheter | |
| K240948 | 2024-06-06 | Imperative Care, Inc. | TracStar LDP Large Distal Platform; Zoom 88 Large Di… | |
| K232542 | 2024-05-16 | MicroVention, Inc. | Wedge XL Delivery Catheter | |
| K233982 | 2024-05-09 | Cerenovus, Inc. | CEREGLIDE 92 Catheter System | |
| K233924 | 2024-04-18 | Neuravi Limited | EMBOGUARD Balloon Guide Catheter | |
| K233201 | 2024-03-27 | Penumbra, Inc. | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Cathete… | |
| K231056 | 2024-03-08 | Wallaby Medical | Esperance Distal Access Catheter | FDA |
| K231218 | 2024-01-19 | Accumedical Beijing , Ltd. | Distal Access Catheter | |
| K233205 | 2023-12-22 | Shanghai Heartcare Medical Technology … | Distal Access Catheter | |
| K233648 | 2023-12-14 | Perfuze, Ltd. | Millipede 088 Access Catheter | |
| K231179 | 2023-12-01 | Anoxia Medical, Inc. | Slinky Catheter | |
| K231393 | 2023-11-30 | Maduro Medical, Inc. | Radical the Dude 7F Guide Catheter | |
| K230726 | 2023-11-29 | Cerenovus, Inc. | CEREGLIDE 92 Intermediate Catheter | |
| K231802 | 2023-09-19 | Perfuze, Ltd. | Millipede 088 Access Catheter | |
| K222948 | 2023-09-19 | Mivi Neuroscience, Inc. | Q Distal Access Catheter | FDA |
| K230775 | 2023-09-14 | MicroVention, Inc. | SOFIA EX Intracranial Support Catheter | |
| K230609 | 2023-09-13 | Balt USA, LLC | NG Delivery Catheter |
Official FDA classification page: QJP
Classification and pathway per current FDA publications. Data from openFDA (CC0).