DQY · Class II · 21 CFR 870.1250

FDA Product Code DQY: Catheter, Percutaneous

Percutaneous catheters are foundational tools in interventional cardiology and vascular medicine. FDA product code DQY covers catheters designed for percutaneous access to the vascular system.

These devices enable clinicians to navigate blood vessels to deliver therapies, measure pressures, or access cardiac structures without open surgery. They are used in angioplasty, electrophysiology, structural heart procedures, and hemodynamic monitoring.

DQY devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic Vascular, Biotronik, Inc. and Vascular Solutions, Inc..

893
Total
893
Cleared
104d
Avg days
1979
Since
893 devices
169–192 of 893
Cleared Jan 26, 2018
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
K173709
Inneuroco, Inc.
Cardiovascular · 53d
Cleared Jan 12, 2018
Microcatheter
K173560
Surmodics,Inc.
Cardiovascular · 56d
Cleared Jan 04, 2018
Attain Assist CS Access Catheter
K171819
Creganna Medical Also Doing Business AS Ceganna Tactx Medica
Cardiovascular · 199d
Cleared Oct 20, 2017
GuideLiner V3 Catheter
K172090
Vascular Solutions, Inc.
Cardiovascular · 101d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452
Boston Scientific Corporation
Cardiovascular · 96d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 03, 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jun 07, 2017
Venture 038 catheter
K171335
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Mar 23, 2017
Guidezilla II Guide Extension Catheter
K163314
Boston Scientific Corporation
Cardiovascular · 120d
Cleared Feb 03, 2017
TrapLiner catheter
K161901
Vascular Solutions, Inc.
Cardiovascular · 207d
Cleared Feb 01, 2017
Twin-Pass Torque
K162467
Vascular Solutions, Inc.
Cardiovascular · 152d
Cleared Jan 05, 2017
YOGA Microcatheter
K162563
Codman & Shurtleff, Inc.
Cardiovascular · 113d
Cleared Aug 25, 2016
ASAHI Corsair Pro
K161126
Asahi Intecc Co., Ltd.
Cardiovascular · 126d
Cleared Jun 14, 2016
ASAHI Corsair Armet
K161362
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Mar 04, 2016
ASAHI Corsair Armet
K152249
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Jan 22, 2016
ASAHI Caravel
K152447
Asahi Intecc Co., Ltd.
Cardiovascular · 148d
Cleared Dec 04, 2015
Stingray LP Catheter
K152401
Boston Scientific Corporation
Cardiovascular · 101d
Cleared Dec 02, 2015
Lantern Delivery Microcatheter
K152840
Penumbra, Inc.
Cardiovascular · 64d
Cleared Nov 13, 2015
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
K151667
Stryker
Cardiovascular · 147d
Cleared Aug 07, 2015
Selectra Catheters and Selectra Accessory Kit
K151409
Biotronik, Inc.
Cardiovascular · 73d
Cleared Jun 23, 2015
ASAHI Corsair Microcatheter
K151103
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared May 12, 2015
Coda LP Balloon Catheter
K150970
Cook Incorporated
Cardiovascular · 29d
Cleared Mar 27, 2015
SOFIA 6F Catheter
K150366
MicroVention, Inc.
Cardiovascular · 43d