FDA Product Code
FDA Product Code QJP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 101 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253422 | OAB Delivery Catheter | Cognition Medical Corp. | 2026-10-02 | Traditional | PDF ↗ |
| K260220 | Route 92 Medical Full Length 046 Access System | Route 92 Medical, Inc. | 2026-09-16 | Traditional | PDF ↗ |
| K262277 | 70 NeuGlide Catheter | Piraeus Medical, Inc. | 2026-09-04 | Special | PDF ↗ |
| K261176 | Zoom 4S Catheter | Imperative Care, Inc. | 2026-08-28 | Traditional | PDF ↗ |
| K254071 | p17 XR Microcatheter | Wallaby Medical | 2026-08-18 | Traditional | PDF ↗ |
| K260199 | SLIM Microcatheter | Balt USA, LLC | 2026-07-13 | Traditional | PDF ↗ |
| K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | 2026-07-09 | Traditional | PDF ↗ |
| K261889 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2026-07-01 | Special | PDF ↗ |
| K261808 | ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro | 2026-06-30 | Special | PDF ↗ |
| K261549 | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | 2026-06-09 | Special | PDF ↗ |
| K253359 | Zenith Distal Access Long Sheath | Suzhou Zenith Vascular SciTech Limited | 2026-05-22 | Traditional | PDF ↗ |
| K254178 | SAYA 86 Radial Access Guide Catheter | Asahi Intecc Co., Ltd. | 2026-05-11 | Traditional | PDF ↗ |
| K254046 | BosCATH Support Catheter | Sonorous NV, Inc. | 2026-04-21 | Traditional | PDF ↗ |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | 2026-04-16 | Traditional | PDF ↗ |
| K260938 | PATH BGC | Crossroads Neurovascular, Inc. | 2026-04-15 | Special | PDF ↗ |
| K253975 | Radical 6F Access Catheter | Maduro Medical, Inc. | 2026-04-09 | Special | PDF ↗ |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2026-02-11 | Traditional | PDF ↗ |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | 2026-01-16 | Traditional | PDF ↗ |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 2026-01-06 | Traditional | PDF ↗ |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. | 2026-01-05 | Traditional | PDF ↗ |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. | 2025-12-03 | Special | PDF ↗ |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc. | 2025-10-24 | Special | PDF ↗ |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | 2025-10-22 | Special | PDF ↗ |
| K250960 | DUO Microcatheter | Rev Neuro, LLC | 2025-09-08 | Traditional | PDF ↗ |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2025-06-20 | Special | PDF ↗ |
| K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2025-06-20 | Traditional | PDF ↗ |
| K251044 | 93 NeuFlex Catheter | Piraeus Medical | 2025-05-23 | Special | PDF ↗ |
| K242392 | PATH BGC | Crossroads Neurovascular, Inc. | 2025-05-09 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| K243593 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | 2025-02-18 | Traditional | PDF ↗ |
| K242051 | VersaD Delivery Catheter | Unity Medical, Inc. | 2025-01-17 | Traditional | PDF ↗ |
| K243577 | Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. | 2025-01-14 | Special | PDF ↗ |
| K243297 | APRO 70 Swift Catheter | Alembic, LLC | 2025-01-14 | Special | PDF ↗ |
| 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 | Special | PDF ↗ |
| K242376 | Next Generation Access Platform | Balt USA, LLC | 2024-12-30 | Traditional | PDF ↗ |
| K241637 | Echo Intracranial Base Catheter | Stryker Neurovascular | 2024-12-19 | Traditional | PDF ↗ |
| K241768 | Broadway 8 Catheter | Stryker Neurovascular | 2024-12-19 | Traditional | PDF ↗ |
| K242033 | Access25 Delivery Microcatheter | Penumbra, Inc. | 2024-12-11 | Traditional | PDF ↗ |
| K240971 | 87 NeuGlide Catheter | Piraeus Medical | 2024-12-06 | Traditional | PDF ↗ |
| K242301 | Socrates 38 Catheter | Scientia Vascular, Inc. | 2024-12-04 | Traditional | PDF ↗ |
| K240746 | Neurovascular Access System Family | Q'Apel Medical, Inc. | 2024-11-20 | Traditional | PDF ↗ |
| K240711 | Zipline Access Catheter | Perfuze, Ltd. | 2024-10-17 | Traditional | PDF ↗ |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | Cerenovus, Inc. | 2024-10-16 | Traditional | PDF ↗ |
| K240529 | 8F Modified Sheath System | Route 92 Medical, Inc. | 2024-10-02 | Special | PDF ↗ |
| K234074 | Next Generation Access Catheter | Balt USA, LLC | 2024-07-02 | Traditional | PDF ↗ |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Imperative Care, Inc. | 2024-06-06 | Traditional | PDF ↗ |
| K232542 | Wedge XL Delivery Catheter | MicroVention, Inc. | 2024-05-16 | Traditional | PDF ↗ |
| K233982 | CEREGLIDE 92 Catheter System | Cerenovus, Inc. | 2024-05-09 | Special | PDF ↗ |
| K233924 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | 2024-04-18 | Special | PDF ↗ |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | Penumbra, Inc. | 2024-03-27 | Traditional | PDF ↗ |
| K231056 | Esperance Distal Access Catheter | Wallaby Medical | 2024-03-08 | Traditional | PDF ↗ |
| K231218 | Distal Access Catheter | Accumedical Beijing , Ltd. | 2024-01-19 | Traditional | PDF ↗ |
| K233205 | Distal Access Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | 2023-12-22 | Traditional | PDF ↗ |
| K233648 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023-12-14 | Special | PDF ↗ |
| K231179 | Slinky Catheter | Anoxia Medical, Inc. | 2023-12-01 | Traditional | PDF ↗ |
| K231393 | Radical the Dude 7F Guide Catheter | Maduro Medical, Inc. | 2023-11-30 | Traditional | PDF ↗ |
| K230726 | CEREGLIDE 92 Intermediate Catheter | Cerenovus, Inc. | 2023-11-29 | Traditional | PDF ↗ |
| K231802 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023-09-19 | Special | PDF ↗ |
| K222948 | Q Distal Access Catheter | Mivi Neuroscience, Inc. | 2023-09-19 | Traditional | PDF ↗ |
| K230775 | SOFIA EX Intracranial Support Catheter | MicroVention, Inc. | 2023-09-14 | Traditional | PDF ↗ |
| K230609 | NG Delivery Catheter | Balt USA, LLC | 2023-09-13 | Traditional | PDF ↗ |
| K223560 | Plato 17 Microcatheter | Scientia Vascular, Inc. | 2023-08-21 | Traditional | PDF ↗ |
| K231583 | Route 92 Medical Full Length 054 Access System | Route 92 Medical, Inc. | 2023-08-15 | Special | PDF ↗ |
| K230322 | SelectFlex Neurovascular Access System Family | Q'Apel Medical, Inc. | 2023-06-22 | Traditional | PDF ↗ |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Imperative Care, Inc. | 2023-05-22 | Special | PDF ↗ |
| K221930 | CEREGLIDE 71 Intermediate Catheter | Cerenovus, Inc. | 2023-03-09 | Traditional | PDF ↗ |
| K223275 | CELLO II Balloon Guide Catheter | Fuji Systems Corporation | 2022-12-09 | Traditional | PDF ↗ |
| K221822 | BENCHMARK BMX81 Access System | Penumbra, Inc. | 2022-11-04 | Traditional | PDF ↗ |
| K221951 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2022-10-11 | Special | PDF ↗ |
| K222743 | Route 92 Medical Full Length 070 Access System | Route 92 Medical, Inc. | 2022-10-04 | Special | PDF ↗ |
| K214048 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2022-09-20 | Traditional | PDF ↗ |
| K213390 | Benchmark BMX96 Access System | Penumbra, Inc. | 2022-08-18 | Traditional | PDF ↗ |
| K212288 | Minjie Catheter System | Kai Medtech, LLC | 2022-06-02 | Traditional | PDF ↗ |
| K213065 | Distal Access Catheter | Guangzhou Easycess Medical Co.,Ltd | 2022-05-31 | Traditional | PDF ↗ |
| K212838 | Benchmark Intracranial Access System | Penumbra, Inc. | 2022-05-27 | Traditional | PDF ↗ |
| K220807 | Imperative Care Radial 088 Access System | Imperative Care, Inc. | 2022-05-17 | Traditional | PDF ↗ |
| K203842 | Bendit21 Microcatheter | Bend IT Technologies, Ltd. | 2022-04-13 | Traditional | PDF ↗ |
| K213589 | FUBUKI XF Neurovascular Long Sheath | Asahi Intecc Co., Ltd. | 2022-03-24 | Traditional | PDF ↗ |
| K213314 | CerusEndo Microcatheter (027) | Cerus Endovascular, Inc. | 2022-03-15 | Traditional | PDF ↗ |
| K202926 | Micro Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | 2022-02-10 | Traditional | PDF ↗ |
| K212340 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | 2021-12-17 | Traditional | PDF ↗ |
| K212402 | MIVI Q Distal Access Catheter | Mivi Neuroscience, Inc. | 2021-12-16 | Special | PDF ↗ |
| K203723 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2021-12-10 | Traditional | PDF ↗ |
| K211594 | Trevo Trak 21 Microcatheter | Stryker Neurovascular | 2021-11-26 | Special | PDF ↗ |
| K213451 | Spartan MC 0165 | Spartan Micro | 2021-11-22 | Traditional | PDF ↗ |
| K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | Imperative Care, Inc. | 2021-09-20 | Special | PDF ↗ |
| K202752 | AXS Vecta 46 Intermediate Catheter | Stryker Neurovascular | 2021-08-27 | Traditional | PDF ↗ |
| K202916 | Balloon Guiding Catheter | Shanghai Heartcare Medical Technology Co., Ltd. | 2021-08-25 | Traditional | PDF ↗ |
| K211893 | SelectFlex Neurovascular Access System Family | Q'Apel Medical, Inc. | 2021-08-05 | Special | PDF ↗ |
| K210635 | Route 92 Medical Full Length 088 Access System | Route 92 Medical, Inc. | 2021-07-27 | Special | PDF ↗ |
| K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform | Imperative Care, Inc. | 2021-03-03 | Traditional | PDF ↗ |
| K203840 | BOSS 8F Balloon Guide Catheter | Marblehead Medical, LLC | 2021-01-28 | Special | PDF ↗ |
| K203043 | Route 92 Medical 070 Access System | Route 92 Medical, Inc. | 2020-11-11 | Special | PDF ↗ |
| K201682 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020-09-28 | Traditional | PDF ↗ |
| K201518 | Route 92 Medical 088 Access System | Route 92 Medical | 2020-08-14 | Traditional | PDF ↗ |
| K201076 | Anchor Dual Lumen Guidewire Catheter | Aqure Medical, Inc. | 2020-08-06 | Traditional | PDF ↗ |
| K200910 | BOSS Balloon Guide Catheter | Marblehead Medical | 2020-05-02 | Traditional | PDF ↗ |
| K200417 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020-05-02 | Traditional | PDF ↗ |
| K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Inc. | 2020-04-18 | Traditional | PDF ↗ |
| K200206 | AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter | Stryker Neurovascular | 2020-02-27 | Special | PDF ↗ |
Product code QJP · Class II · Cardiovascular. Data: openFDA.