Panels › Cardiovascular › Product code QJP · Class 2
Catheter, Percutaneous, Neurovasculature
Regulation 870.1250
23510(k)s in 12 months (103 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in QJP
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Neurovascular | 10 | 2 |
| Route 92 Medical | 8 | 2 |
| Asahi Intecc Co., Ltd. | 6 | 0 |
| Balt USA, LLC | 6 | 0 |
| Imperative Care, Inc. | 6 | 0 |
| Penumbra, Inc. | 5 | 0 |
| Perfuze, Ltd. | 5 | 0 |
| Cerenovus, Inc. | 4 | 0 |
| Maduro Medical, Inc. | 3 | 0 |
| Piraeus Medical | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K261649 | Excelsior Reach Microcatheter Stryker Neurovascular | QJP |
| Oct 6, 2026 | K261938 | APRO 88 Catheter Alembic, LLC | QJP |
| Oct 2, 2026 | K253422 | OAB Delivery Catheter Cognition Medical Corp. | QJP |
| Sep 16, 2026 | K260220 | Route 92 Medical Full Length 046 Access System Route 92 Medical, Inc. | QJP |
| Sep 4, 2026 | K262277 | 70 NeuGlide Catheter Piraeus Medical, Inc. | QJP |
| Aug 28, 2026 | K261176 | Zoom 4S Catheter Imperative Care, Inc. | QJP |
| Aug 18, 2026 | K254071 | p17 XR Microcatheter Wallaby Medical | QJP |
| Jul 13, 2026 | K260199 | SLIM Microcatheter Balt USA, LLC | QJP |
| Jul 9, 2026 | K253901 | Millipede88 Access Catheter Perfuze, Ltd., IE | QJP |
| Jul 1, 2026 | K261889 | Trevo Trak 21 Microcatheter Stryker Neurovascular | QJP |
| Jun 30, 2026 | K261808 | ISAAC Neurovascular Navigation Catheter Microvention Inc. d/b/a Terumo Neuro | QJP |
| Jun 9, 2026 | K261549 | BOBBY Balloon Guide Catheter MicroVention, Inc., d/b/a Terumo Neuro | QJP |
| May 22, 2026 | K253359 | Zenith Distal Access Long Sheath Suzhou Zenith Vascular SciTech Limited, CN | QJP |
| May 11, 2026 | K254178 | SAYA 86 Radial Access Guide Catheter Asahi Intecc Co., Ltd., JP | QJP |
| Apr 21, 2026 | K254046 | BosCATH Support Catheter Sonorous NV, Inc. | QJP |
| Apr 16, 2026 | K254223 | Next Generation 088 Catheter Balt USA, LLC | QJP |
| Apr 15, 2026 | K260938 | PATH BGC Crossroads Neurovascular, Inc. | QJP |
| Apr 9, 2026 | K253975 | Radical 6F Access Catheter Maduro Medical, Inc. | QJP |
| Feb 11, 2026 | K253032 | AXS Lift Intracranial Base Catheter Stryker Neurovascular | QJP |
| Jan 16, 2026 | K252297 | Toro 88 Superbore Catheter Toro Neurovascular, Inc. | QJP |
| Jan 6, 2026 | K251097 | V-DAC Catheter Vesalio, Inc. | QJP |
| Jan 5, 2026 | K251668 | SurfRider 13 Microcatheter Kaneka Americas Holding, Inc. | QJP |
| Dec 3, 2025 | K252213 | Bendit17 Microcatheter Bend IT Technologies, Ltd., IL | QJP |
| Oct 24, 2025 | K251372 | VersaD Delivery Catheter Unity Medical, Inc. | QJP |
| Oct 22, 2025 | K252569 | Carrier XL Delivery Catheter Balt USA, LLC | QJP |
| Sep 8, 2025 | K250960 | DUO Microcatheter Rev Neuro, LLC | QJP |
| Jun 20, 2025 | K251560 | FUBUKI XF-R Neurovascular Long Sheath Asahi Intecc Co., Ltd., JP | QJP |
| Jun 20, 2025 | K251240 | Branchor X Balloon Guide Catheter Asahi Intecc Co., Ltd., JP | QJP |
| May 23, 2025 | K251044 | 93 NeuFlex Catheter Piraeus Medical | QJP |
| May 9, 2025 | K242392 | PATH BGC Crossroads Neurovascular, Inc. | QJP |
| Mar 21, 2025 | K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior X Stryker Neurovascular | QJP |
| Feb 18, 2025 | K243593 | AXS Lift Intracranial Base Catheter Stryker Neurovascular | QJP |
| Jan 17, 2025 | K242051 | VersaD Delivery Catheter Unity Medical, Inc. | QJP |
| Jan 14, 2025 | K243577 | Radical the Dude 8F Guide Catheter Maduro Medical, Inc. | QJP |
| Jan 14, 2025 | K243297 | APRO 70 Swift Catheter Alembic, LLC | QJP |
| Jan 2, 2025 | 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 | QJP |
| Dec 30, 2024 | K242376 | Next Generation Access Platform Balt USA, LLC | QJP |
| Dec 19, 2024 | K241768 | Broadway 8 Catheter Stryker Neurovascular | QJP |
| Dec 19, 2024 | K241637 | Echo Intracranial Base Catheter Stryker Neurovascular | QJP |
| Dec 11, 2024 | K242033 | Access25 Delivery Microcatheter Penumbra, Inc. | QJP |
| Dec 6, 2024 | K240971 | 87 NeuGlide Catheter Piraeus Medical | QJP |
| Dec 4, 2024 | K242301 | Socrates 38 Catheter Scientia Vascular, Inc. | QJP |
| Nov 20, 2024 | K240746 | Neurovascular Access System Family Q'Apel Medical, Inc. | QJP |
| Oct 17, 2024 | K240711 | Zipline Access Catheter Perfuze, Ltd., IE | QJP |
| Oct 16, 2024 | K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter Cerenovus, Inc. | QJP |
| Oct 2, 2024 | K240529 | 8F Modified Sheath System Route 92 Medical, Inc. | QJP |
| Jul 2, 2024 | K234074 | Next Generation Access Catheter Balt USA, LLC | QJP |
| Jun 6, 2024 | K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support Imperative Care, Inc. | QJP |
| May 16, 2024 | K232542 | Wedge XL Delivery Catheter MicroVention, Inc. | QJP |
| May 9, 2024 | K233982 | CEREGLIDE 92 Catheter System Cerenovus, Inc. | QJP |
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