ClearanceBrief
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)
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Top companies in QJP

Company510(k)sRecalls
Stryker Neurovascular102
Route 92 Medical82
Asahi Intecc Co., Ltd.60
Balt USA, LLC60
Imperative Care, Inc.60
Penumbra, Inc.50
Perfuze, Ltd.50
Cerenovus, Inc.40
Maduro Medical, Inc.30
Piraeus Medical30
Decided510(k)Device and applicantCode
Apr 18, 2024K233924EMBOGUARD Balloon Guide Catheter
Neuravi Limited, IE
QJP
Mar 27, 2024K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
Penumbra, Inc.
QJP
Mar 8, 2024K231056Esperance Distal Access Catheter
Wallaby Medical
QJP
Jan 19, 2024K231218Distal Access Catheter
Accumedical Beijing , Ltd., CN
QJP
Dec 22, 2023K233205Distal Access Catheter
Shanghai Heartcare Medical Technology Co., Ltd., CN
QJP
Dec 14, 2023K233648Millipede 088 Access Catheter
Perfuze, Ltd., IE
QJP
Dec 1, 2023K231179Slinky Catheter
Anoxia Medical, Inc.
QJP
Nov 30, 2023K231393Radical the Dude 7F Guide Catheter
Maduro Medical, Inc.
QJP
Nov 29, 2023K230726CEREGLIDE 92 Intermediate Catheter
Cerenovus, Inc.
QJP
Sep 19, 2023K231802Millipede 088 Access Catheter
Perfuze, Ltd., IE
QJP
Sep 19, 2023K222948Q Distal Access Catheter
Mivi Neuroscience, Inc.
QJP
Sep 14, 2023K230775SOFIA EX Intracranial Support Catheter
MicroVention, Inc.
QJP
Sep 13, 2023K230609NG Delivery Catheter
Balt USA, LLC
QJP
Aug 21, 2023K223560Plato 17 Microcatheter
Scientia Vascular, Inc.
QJP
Aug 15, 2023K231583Route 92 Medical Full Length 054 Access System
Route 92 Medical, Inc.
QJP
Jun 22, 2023K230322SelectFlex Neurovascular Access System Family
Q'Apel Medical, Inc.
QJP
May 22, 2023K231168TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Imperative Care, Inc.
QJP
Mar 9, 2023K221930CEREGLIDE 71 Intermediate Catheter
Cerenovus, Inc.
QJP
Dec 9, 2022K223275CELLO II Balloon Guide Catheter
Fuji Systems Corporation, JP
QJP
Nov 4, 2022K221822BENCHMARK BMX81 Access System
Penumbra, Inc.
QJP
Oct 11, 2022K221951Branchor Balloon Guide Catheter
Asahi Intecc Co., Ltd., JP
QJP
Oct 4, 2022K222743Route 92 Medical Full Length 070 Access System
Route 92 Medical, Inc.
QJP
Sep 20, 2022K214048Millipede 088 Access Catheter
Perfuze, Ltd., IE
QJP
Aug 18, 2022K213390Benchmark BMX96 Access System
Penumbra, Inc.
QJP
Jun 2, 2022K212288Minjie Catheter System
Kai Medtech, LLC
QJP
May 31, 2022K213065Distal Access Catheter
Guangzhou Easycess Medical Co.,Ltd, CN
QJP
May 27, 2022K212838Benchmark Intracranial Access System
Penumbra, Inc.
QJP
May 17, 2022K220807Imperative Care Radial 088 Access System
Imperative Care, Inc.
QJP
Apr 13, 2022K203842Bendit21 Microcatheter
Bend IT Technologies, Ltd., IL
QJP
Mar 24, 2022K213589FUBUKI XF Neurovascular Long Sheath
Asahi Intecc Co., Ltd., JP
QJP
Mar 15, 2022K213314CerusEndo Microcatheter (027)
Cerus Endovascular, Inc.
QJP
Feb 10, 2022K202926Micro Catheter
Shanghai Heartcare Medical Technology Co., Ltd., CN
QJP
Dec 17, 2021K212340EMBOGUARD Balloon Guide Catheter
Neuravi Limited, IE
QJP
Dec 16, 2021K212402MIVI Q Distal Access Catheter
Mivi Neuroscience, Inc.
QJP
Dec 10, 2021K203723Branchor Balloon Guide Catheter
Asahi Intecc Co., Ltd., JP
QJP
Nov 26, 2021K211594Trevo Trak 21 Microcatheter
Stryker Neurovascular
QJP
Nov 22, 2021K213451Spartan MC 0165
Spartan Micro
QJP
Sep 20, 2021K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Imperative Care, Inc.
QJP
Aug 27, 2021K202752AXS Vecta 46 Intermediate Catheter
Stryker Neurovascular
QJP
Aug 25, 2021K202916Balloon Guiding Catheter
Shanghai Heartcare Medical Technology Co., Ltd., CN
QJP
Aug 5, 2021K211893SelectFlex Neurovascular Access System Family
Q'Apel Medical, Inc.
QJP
Jul 27, 2021K210635Route 92 Medical Full Length 088 Access System
Route 92 Medical, Inc.
QJP
Mar 3, 2021K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Imperative Care, Inc.
QJP
Jan 28, 2021K203840BOSS 8F Balloon Guide Catheter
Marblehead Medical, LLC
QJP
Nov 11, 2020K203043Route 92 Medical 070 Access System
Route 92 Medical, Inc.
QJP
Sep 28, 2020K201682RIST Radial Access Catheter
Rist Neurovascular, Inc.
QJP
Aug 14, 2020K201518Route 92 Medical 088 Access System
Route 92 Medical
QJP
Aug 6, 2020K201076Anchor Dual Lumen Guidewire Catheter
Aqure Medical, Inc.
QJP
May 2, 2020K200910BOSS Balloon Guide Catheter
Marblehead Medical
QJP
May 2, 2020K200417RIST Radial Access Catheter
Rist Neurovascular, Inc.
QJP

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