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 13, 2019K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Ac
Stryker
DQY
Mar 13, 2019K182570Venture 0.014 Catheter
Vascular Solutions, LLC
DQY
Dec 29, 2018K183000ViperCath XC Peripheral Exchange Catheter
Cardiovascular Systems, Inc.
DQY
Dec 20, 2018K182420ASAHI Corsair Pro XS
Asahi Intecc Co., Ltd., JP
DQY
Dec 14, 2018K180797Xcess Guiding Catheter
Curatia Medical Co.
DQY
Dec 13, 2018K183265Selectra Catheters, Selectra Accessory Kit
Biotronik, Inc.
DQY
Dec 10, 2018K182512Route 92 Medical Delivery Catheter
Route 92 Medical, Inc.
DQY
Dec 7, 2018K180889Tractus Crossing Support Catheter
Tractus Vascular, LLC
DQY
Nov 14, 2018K182097React 71 Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
DQY
Nov 9, 2018K182360Teleport Microcatheter
Orbusneich Medical Trading, Inc.
DQY
Oct 5, 2018K180919GORE Tri-Lumen Catheter
W. L. Gore and Associates, Inc.
DQY
Sep 26, 2018K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
Access Scientific, LLC
DQY
Sep 13, 2018K181000SelectFlex 072 Neurovascular Access System
Q'Apel
DQY
Aug 8, 2018K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, E
Imperative Care, Inc.
DQY
Jul 20, 2018K180864WATCHMAN TruSeal Access System
Boston Scientific
DQY
Jul 4, 2018K180715React 68 Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
DQY
Jun 11, 2018K180959Phenom 27 Catheter
Cathera, Inc.
DQY
May 23, 2018K180201Route 92 Medical Access System
Route 92 Medical, Inc.
DQY
May 15, 2018K180986XableCath Support Catheter Product Family
Xablecath, Inc.
DQY
Apr 18, 2018K173661Wingman 35 Crossing Catheter
Reflow Medical, Inc.
DQY
Apr 5, 2018K172014Wedge Microcatheter
MicroVention, Inc.
DQY
Apr 4, 2018K180088TrapLiner catheter
Vascular Solutions, Inc.
DQY
Mar 30, 2018K173548Merit Pursue Microcatheter
Merit Medical Systems, Inc.
DQY
Mar 29, 2018K173799NaviCross 0.018
Terumo Corporation, JP
DQY
Jan 26, 2018K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
Inneuroco, Inc.
DQY
Jan 12, 2018K173560Microcatheter
Surmodics,Inc.
DQY
Jan 4, 2018K171819Attain Assist CS Access Catheter
Creganna Medical Also Doing Business AS Ceganna Tactx Medica, IE
DQY
Dec 20, 2017K173662speX Support Catheter
Reflow Medical, Inc.
DQY
Dec 6, 2017K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
Inneuroco, Inc.
DQY
Nov 21, 2017K170914TXM Support Catheter
Texasmedical Technologies, Inc.
DQY
Nov 9, 2017K170664Odyssey Micro Catheter
Heraeus Medical Components, LLC
DQY
Oct 20, 2017K172090GuideLiner V3 Catheter
Vascular Solutions, Inc.
DQY
Oct 19, 2017K171672065 Zenith, 074 Zenith
Inneuroco, Inc.
DQY
Oct 18, 2017K172297NovaCross Microcatheter
Nitiloop , Ltd., IL
DQY
Sep 15, 2017K171176M-CATH Microcatheter
Acrostak (Schweiz) AG, CH
DQY
Sep 7, 2017K170041XableCath Support Catheter
Xablecath, Inc.
DQY
Aug 21, 2017K171452MAMBA and MAMBA FLEX Microcatheters
Boston Scientific Corporation
DQY
Jul 28, 2017K163259AXS Offset Delivery Assist Catheter
Stryker Neurovascular
DQY
Jul 25, 2017K171913Rubicon 14, 18 and 35 Support Catheters
Boston Scientific Corporation
DQY
Jul 3, 2017K171653YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
Codman & Shurtleff, Inc.
DQY
Jun 30, 2017K171612ACUITY Pro Lead Delivery System
Boston Scientific Corporation
DQY
Jun 23, 2017K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Se
Arrow International, Inc. (Subsidiary of Telelflex Inc.)
DQY
Jun 9, 2017K170996Wingman 14C Crossing Catheter
Reflow Medical, Inc.
DQY
Jun 7, 2017K171335Venture 038 catheter
Vascular Solutions, Inc.
DQY
May 31, 2017K171268Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
DQY
Apr 6, 2017K163233MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter,
Mivi Neuroscience, Inc.
DQY
Mar 23, 2017K163314Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter
Boston Scientific Corporation
DQY
Mar 7, 2017K170403CenterCross Ultra LV Catheter
Roxwood Medical, Inc.
DQY
Feb 18, 2017K162565VIA 17 Microcatheter
Sequent Medical, Inc.
DQY
Feb 3, 2017K161901TrapLiner catheter
Vascular Solutions, Inc.
DQY

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