ClearanceBrief
Panels › Cardiovascular › Product code DQY · Class 2

Catheter, Percutaneous

Regulation 870.1250

13510(k)s in 12 months (896 all time)
2recalls in 12 months (620 all time)
583recalls that name a 510(k)
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Top companies in DQY

Company510(k)sRecalls
Medtronic Vascular31198
Medtronic15148
Boston Scientific3059
ARROW INTERNATIONAL, LLC041
Stryker Neurovascular630
Cook Incorporated2213
Vascular Solutions, Inc.276
Codman & Shurtleff, Inc.824
Bard Peripheral Vascular, Inc.523
Cordis Corp.224
Decided510(k)Device and applicantCode
Mar 1, 2021K203275Recon Support Catheter
C.R. Bard, Inc.
DQY
Feb 25, 2021K210230Phenom Catheters
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
DQY
Dec 14, 2020K202610Ventrax Delivery System
Merit Medical Systems, Inc.
DQY
Oct 26, 2020K201811coraForce and coraFlex Support Catheters
Reflow Medical, Inc.
DQY
Oct 16, 2020K193474Selectra 3D Outer Guiding Catheters
Biotronik, Inc.
DQY
Sep 8, 2020K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), AS
Asahi Intecc Co., Ltd., JP
DQY
Aug 6, 2020K200324NHancer Rx
Imds Operations B.V., NL
DQY
Aug 3, 2020K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Com
Medtronic, Inc., IE
DQY
Jul 21, 2020K193607BOBBY Balloon Guide Catheter
MicroVention, Inc.
DQY
Jun 29, 2020K193119Twin-Pass Dual Access Catheter
Vascular Solutions, LLC
DQY
Jun 11, 2020K201271Benchmark BMX96 Access System
Penumbra, Inc.
DQY
Jun 3, 2020K200721Agilis HisPro Steerable Catheter With Electrodes
Abbott (St. Jude Medical)
DQY
May 14, 2020K200317Support Catheter
Qxmedical, LLC
DQY
May 6, 2020K193420XO Cross Support Catheter
Transit Scientific
DQY
Apr 6, 2020K192558Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
Mivi Neurovascular
DQY
Apr 2, 2020K193322NovaCross CTO Microcatheter
Nitiloop , Ltd., IL
DQY
Mar 18, 2020K200094speX LP Support Catheter
Reflow Medical
DQY
Feb 20, 2020K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35
Reflow Medical
DQY
Feb 19, 2020K193012speX Support Catheter
Reflow Medical
DQY
Jan 21, 2020K191229TrapIt
Imds Operations B.V., NL
DQY
Jan 13, 2020K191717Route 92 Medical Sheath System
Route 92 Medical, Inc.
DQY
Jan 7, 2020K192774BioCardia 8F Morph DNA Deflectable Guide Catheter
Biocardia
DQY
Dec 24, 2019K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
MicroVention, Inc.
DQY
Dec 23, 2019K191551RIST Cath Radial Access Long Sheath
Rist Neurovascular, Inc.
DQY
Dec 15, 2019K190833AXS Vecta Aspiration Catheter
Stryker Neurovascular
DQY
Dec 12, 2019K191163Lumax Guiding Catheter
Cook Incorporated
DQY
Nov 29, 2019K193034AXS Infinity LS Plus Long Sheath
Stryker Neurovascular
DQY
Nov 29, 2019K192782ASAHI CROSSWALK Peripheral Support Catheter
Asahi Intecc Co., Ltd., JP
DQY
Nov 21, 2019K192996Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
Biotronik, Inc.
DQY
Nov 21, 2019K192625PG Pro Microcatheter
MicroVention, Inc. A TERUMO Group Company
DQY
Nov 8, 2019K191237CERENOVUS Large Bore Catheter
Codman & Shurtleff, Inc.
DQY
Oct 31, 2019K192525087 Balloon Guide Catheter System
Q'Apel Medical, LLC
DQY
Sep 20, 2019K192296Medtronic 6F Taiga Guiding Catheter
Medtronic Vascular
DQY
Aug 30, 2019K191664SelectFlex 072 Neurovascular Access System
Q'Apel Medical
DQY
Aug 9, 2019K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter
Vascular Solutions, LLC
DQY
Aug 5, 2019K183305Crossing Support Catheter
Tractus Vascular, LLC
DQY
Jul 20, 2019K182487CerusEndo Microcatheter
Cerus Endovascular, Inc.
DQY
Jul 15, 2019K190749087 Balloon Guide Catheter System
Q'Apel
DQY
Jul 10, 2019K182829Scepter Mini Occlusion Balloon Catheter
MicroVention, Inc.
DQY
Jun 28, 2019K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4
Centerpoint Systems
DQY
Jun 22, 2019K182844ASAHI SASUKE
Asahi Intecc Co., Ltd., JP
DQY
May 23, 2019K182937Upstream GoBack Crossing Catheter
Upstream Peripheral Technologies, Ltd., IL
DQY
May 15, 2019K182602SOFIA EX Intracranial Support Catheter
MicroVention, Inc.
DQY
May 9, 2019K190393Wingman 14C Crossing Catheter
Reflow Medical, Inc.
DQY
Apr 5, 2019K190581Amplatzer Trevisio Intravascular Delivery System
ABBOTT MEDICAL
DQY
Mar 22, 2019K183353Telescope Guide Extension Catheter
Medtronic, Inc., IE
DQY
Mar 21, 2019K190431Route 92 Medical Delivery Catheter
Route 92 Medical, Inc.
DQY
Mar 21, 2019K182918Ballast 088 Long Sheath
Balt USA, LLC
DQY
Mar 15, 2019K190401MAMBA and MAMBA Flex Microcatheters
Boston Scientific Corporation
DQY
Mar 15, 2019K183493SelectSite C304-HIS Deflectable Catheter System
Medtronic, Inc., IE
DQY

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