Atlas FDA

QJP

96 FDA 510(k) clearances · Product code

143 daysmedian time to decision
271 days90th percentile
96clearances measured

FDA profile

Official device name
Catheter, Percutaneous, Neurovasculature
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Medical specialty
Cardiovascular
FDA definition
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Adverse events (MAUDE)
2021: 29 · 2022: 30 · 2023: 75 · 2024: 133 · 2025: 700 · 2026: 686
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SLIM Microcatheter (K260199)Balt USA, LLC2026-07-13
Millipede88 Access Catheter (K253901)Perfuze, Ltd.2026-07-09
Trevo Trak 21 Microcatheter (K261889)Stryker Neurovascular2026-07-01
ISAAC Neurovascular Navigation Catheter (K261808)Microvention Inc. d/b/a Terumo Neuro2026-06-30
BOBBY Balloon Guide Catheter (K261549)MicroVention, Inc., d/b/a Terumo Neuro2026-06-09
Zenith Distal Access Long Sheath (K253359)Suzhou Zenith Vascular SciTech Limited2026-05-22
SAYA 86 Radial Access Guide Catheter (K254178)Asahi Intecc Co., Ltd.2026-05-11
BosCATH Support Catheter (K254046)Sonorous NV, Inc.2026-04-21
Next Generation 088 Catheter (K254223)Balt USA, LLC2026-04-16
PATH BGC (K260938)Crossroads Neurovascular, Inc.2026-04-15
Radical 6F Access Catheter (K253975)Maduro Medical, Inc.2026-04-09
AXS Lift Intracranial Base Catheter (K253032)Stryker Neurovascular2026-02-11
Toro 88 Superbore Catheter (K252297)Toro Neurovascular, Inc.2026-01-16
V-DAC Catheter (K251097)Vesalio, Inc.2026-01-06
SurfRider 13 Microcatheter (K251668)Kaneka Americas Holding, Inc.2026-01-05
Bendit17 Microcatheter (K252213)Bend IT Technologies, Ltd.2025-12-03
VersaD Delivery Catheter (K251372)Unity Medical, Inc.2025-10-24
Carrier XL Delivery Catheter (K252569)Balt USA, LLC2025-10-22
DUO Microcatheter (K250960)Rev Neuro, LLC2025-09-08
FUBUKI XF-R Neurovascular Long Sheath (K251560)Asahi Intecc Co., Ltd.2025-06-20
Branchor X Balloon Guide Catheter (K251240)Asahi Intecc Co., Ltd.2025-06-20
93 NeuFlex Catheter (K251044)Piraeus Medical2025-05-23
PATH BGC (K242392)Crossroads Neurovascular, Inc.2025-05-09
Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter (K242289)Stryker Neurovascular2025-03-21
AXS Lift Intracranial Base Catheter (K243593)Stryker Neurovascular2025-02-18
VersaD Delivery Catheter (K242051)Unity Medical, Inc.2025-01-17
Radical the Dude 8F Guide Catheter (K243577)Maduro Medical, Inc.2025-01-14
APRO 70 Swift Catheter (K243297)Alembic, LLC2025-01-14
Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (K241388)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2025-01-02
Next Generation Access Platform (K242376)Balt USA, LLC2024-12-30
Broadway 8 Catheter (K241768)Stryker Neurovascular2024-12-19
Echo Intracranial Base Catheter (K241637)Stryker Neurovascular2024-12-19
Access25™ Delivery Microcatheter (K242033)Penumbra, Inc.2024-12-11
87 NeuGlide Catheter (K240971)Piraeus Medical2024-12-06
Socrates 38 Catheter (K242301)Scientia Vascular, Inc.2024-12-04
Neurovascular Access System Family (K240746)Q'Apel Medical, Inc.2024-11-20
Zipline Access Catheter (K240711)Perfuze, Ltd.2024-10-17
CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter (K241244)Cerenovus, Inc.2024-10-16
8F Modified Sheath System (K240529)Route 92 Medical, Inc.2024-10-02
Next Generation Access Catheter (K234074)Balt USA, LLC2024-07-02
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K240948)Imperative Care, Inc.2024-06-06
Wedge XL Delivery Catheter (K232542)MicroVention, Inc.2024-05-16
CEREGLIDE 92 Catheter System (K233982)Cerenovus, Inc.2024-05-09
EMBOGUARD Balloon Guide Catheter (K233924)Neuravi Limited2024-04-18
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) (K233201)Penumbra, Inc.2024-03-27
Esperance Distal Access Catheter (K231056)Wallaby Medical2024-03-08
Distal Access Catheter (K231218)Accumedical Beijing , Ltd.2024-01-19
Distal Access Catheter (K233205)Shanghai Heartcare Medical Technology Co., Ltd.2023-12-22
Millipede 088 Access Catheter (K233648)Perfuze, Ltd.2023-12-14
Slinky Catheter (K231179)Anoxia Medical, Inc.2023-12-01
Radical the Dude 7F Guide Catheter (K231393)Maduro Medical, Inc.2023-11-30
CEREGLIDE 92 Intermediate Catheter (K230726)Cerenovus, Inc.2023-11-29
Millipede 088 Access Catheter (K231802)Perfuze, Ltd.2023-09-19
Q Distal Access Catheter (K222948)Mivi Neuroscience, Inc.2023-09-19
SOFIA EX Intracranial Support Catheter (K230775)MicroVention, Inc.2023-09-14
NG Delivery Catheter (K230609)Balt USA, LLC2023-09-13
Plato 17 Microcatheter (K223560)Scientia Vascular, Inc.2023-08-21
Route 92 Medical Full Length 054 Access System (K231583)Route 92 Medical, Inc.2023-08-15
SelectFlex Neurovascular Access System Family (K230322)Q'Apel Medical, Inc.2023-06-22
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K231168)Imperative Care, Inc.2023-05-22
CEREGLIDE 71 Intermediate Catheter (K221930)Cerenovus, Inc.2023-03-09
CELLO II Balloon Guide Catheter (K223275)Fuji Systems Corporation2022-12-09
BENCHMARK BMX81 Access System (K221822)Penumbra, Inc.2022-11-04
Branchor Balloon Guide Catheter (K221951)Asahi Intecc Co., Ltd.2022-10-11
Route 92 Medical Full Length 070 Access System (K222743)Route 92 Medical, Inc.2022-10-04
Millipede 088 Access Catheter (K214048)Perfuze, Ltd.2022-09-20
Benchmark BMX96 Access System (K213390)Penumbra, Inc.2022-08-18
Minjie Catheter System (K212288)Kai Medtech, LLC2022-06-02
Distal Access Catheter (K213065)Guangzhou Easycess Medical Co.,Ltd2022-05-31
Benchmark Intracranial Access System (K212838)Penumbra, Inc.2022-05-27
Imperative Care Radial 088 Access System (K220807)Imperative Care, Inc.2022-05-17
Bendit21 Microcatheter (K203842)Bend IT Technologies, Ltd.2022-04-13
FUBUKI XF Neurovascular Long Sheath (K213589)Asahi Intecc Co., Ltd.2022-03-24
CerusEndo Microcatheter (027) (K213314)Cerus Endovascular, Inc.2022-03-15
Micro Catheter (K202926)Shanghai Heartcare Medical Technology Co., Ltd.2022-02-10
EMBOGUARD Balloon Guide Catheter (K212340)Neuravi Limited2021-12-17
MIVI Q Distal Access Catheter (K212402)Mivi Neuroscience, Inc.2021-12-16
Branchor Balloon Guide Catheter (K203723)Asahi Intecc Co., Ltd.2021-12-10
Trevo Trak 21 Microcatheter (K211594)Stryker Neurovascular2021-11-26
Spartan MC 0165 (K213451)Spartan Micro2021-11-22
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform (K212224)Imperative Care, Inc.2021-09-20
AXS Vecta 46 Intermediate Catheter (K202752)Stryker Neurovascular2021-08-27
Balloon Guiding Catheter (K202916)Shanghai Heartcare Medical Technology Co., Ltd.2021-08-25
SelectFlex Neurovascular Access System Family (K211893)Q'Apel Medical, Inc.2021-08-05
Route 92 Medical Full Length 088 Access System (K210635)Route 92 Medical, Inc.2021-07-27
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (K203764)Imperative Care, Inc.2021-03-03
BOSS 8F Balloon Guide Catheter (K203840)Marblehead Medical, LLC2021-01-28
Route 92 Medical 070 Access System (K203043)Route 92 Medical, Inc.2020-11-11
RIST Radial Access Catheter (K201682)Rist Neurovascular, Inc.2020-09-28
Route 92 Medical 088 Access System (K201518)Route 92 Medical2020-08-14
Anchor Dual Lumen Guidewire Catheter (K201076)Aqure Medical, Inc.2020-08-06
BOSS Balloon Guide Catheter (K200910)Marblehead Medical2020-05-02
RIST Radial Access Catheter (K200417)Rist Neurovascular, Inc.2020-05-02
Route 92 Medical 088 Access System, 110 cm (K200121)Route 92 Medical, Inc.2020-04-18
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter (K200206)Stryker Neurovascular2020-02-27
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm (K192804)Medos International SARL2020-02-27

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