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
Oct 31, 2023K231629091 Balloon Guide Catheter
Eosolutions, Corp.
DQY
Oct 13, 2023K232437Paragon 8F Balloon Guide Catheter
Wallaby Medical
DQY
Sep 29, 2023K232690Amulet™ Steerable Delivery Sheath
ABBOTT MEDICAL
DQY
Sep 29, 2023K232647Microcatheter
Surmodics,Inc.
DQY
Aug 30, 2023K231246Ventrax™ Delivery System (VTR851)
Merit Medical Systems, Inc.
DQY
Aug 22, 2023K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
Medtronic Vascular
DQY
Aug 8, 2023K223633Rubicon™ Control Support Catheter (H749394323506A1)
Boston Scientific Corporation
DQY
Jul 27, 2023K231044R2P Navicross
Terumo Medical Corporation
DQY
Jul 13, 2023K223728Micro Rx
Imds Operations B.V., NL
DQY
Jun 30, 2023K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
Medtronic Vascular
DQY
Jun 2, 2023K231311CPS Direct™ Universal slittable outer guide catheter (DS2C029)
ABBOTT MEDICAL
DQY
May 25, 2023K231176Stingray LP Catheter
Boston Scientific
DQY
Apr 6, 2023K222023RayFlow
Hexacath, FR
DQY
Mar 9, 2023K230363CPS Locator 3D Delivery Catheter
CenterPoint Systems, LLC
DQY
Mar 2, 2023K2226036F Wallaby Long Sheath
Wallaby Medical, Inc.
DQY
Jan 10, 2023K222115ISAAC Neurovascular Navigation Catheter
MicroVention, Inc.
DQY
Nov 8, 2022K223178SelectSite C304 Deflectable Catheter System, C315 Delivery System
Medtronic
DQY
Nov 7, 2022K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
Medtronic
DQY
Oct 20, 2022K213466Houdini Cross Support Catheter
Cruzar Medsystems, Inc.
DQY
Oct 14, 2022K221886Sublime Microcatheter
Surmodics,Inc.
DQY
Sep 12, 2022K214024SOFIA 88 Catheter
MicroVention, Inc.
DQY
Aug 18, 2022K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Vascular Solutions, LLC
DQY
Jul 29, 2022K220331091 Balloon Guide Catheter
Inneuroco, Inc.
DQY
Jul 19, 2022K222037Selectra Lead Implantation System
Biotronik, Inc.
DQY
Jul 11, 2022K221846Artix Ballon Guiding Sheath
Inari Medical
DQY
Jun 30, 2022K221750CPS AIM Universal II Slittable Inner Catheter
ABBOTT MEDICAL
DQY
Jun 2, 2022K220632Boss Crossing Support Catheter
Marvao Medical Devices, Ltd., IE
DQY
May 5, 2022K220716Spartan SC 069
Spartan Micro, Inc.
DQY
May 5, 2022K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
Seigla Medical, Inc.
DQY
May 4, 2022K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon
C.R. Bard, Inc.
DQY
Apr 11, 2022K214107XO CROSS CORONARY Support Catheter
Transit Scientific, LLC
DQY
Mar 9, 2022K220340Amplatzer Steerable Delivery Sheath
ABBOTT MEDICAL
DQY
Feb 9, 2022K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapL
Vascular Solutions, LLC
DQY
Jan 28, 2022K214106QuikPass Catheter
Traverse Vascular, Inc.
DQY
Nov 24, 2021K210009Guiding Catheter
CenterPoint Systems, LLC
DQY
Oct 21, 2021K210322XO Cross Support Catheter
Transit Scientific, LLC
DQY
Sep 27, 2021K212738Amplatzer Talisman Delivery Sheath
ABBOTT MEDICAL
DQY
Sep 27, 2021K212026Amplatzer Steerable Delivery Sheath
ABBOTT MEDICAL
DQY
Sep 24, 2021K212725ViperCross Support Catheters
Cardiovascular Systems, Inc.
DQY
Aug 26, 2021K211240ViperCross Support Catheters
Cardiovascular Systems, Inc.
DQY
Aug 13, 2021K212228WATCHMAN FXD Curve Access System
Boston Scientific Corporation
DQY
Jul 27, 2021K211990Rist 071 Radial Access Guide Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
DQY
Jul 15, 2021K210431ReCross
Imds Operations B.V., NL
DQY
Jul 7, 2021K201726Arterial Catheter
Haolang Medical USA Corporation
DQY
May 28, 2021K210188coraCross
Reflow Medical
DQY
May 26, 2021K211251ViperCath XC Peripheral Exchange Catheter
Cardiovascular Systems, Inc.
DQY
Apr 30, 2021K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
Vascular Solutions, LLC
DQY
Apr 28, 2021K210601Plato 17 Microcatheter
Scientia Vascular, LLC
DQY
Mar 31, 2021K210110Guidion
Imds Operations B.V., NL
DQY
Mar 3, 2021K203521FineCross M3
Ashitaka Factory of Terumo Corporation, JP
DQY

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