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
313–336 of 893
Cleared Oct 06, 2006
MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K062609
AngioDynamics, Inc.
Cardiovascular · 31d
Cleared Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K062594
Boston Scientific Corporation
Cardiovascular · 19d
Cleared Sep 08, 2006
5F SHERPA ACTIVE NX GUIDE CATHETER
K062420
Medtronic Vascular
Cardiovascular · 21d
Cleared Aug 01, 2006
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K061843
St Jude Medical
Cardiovascular · 32d
Cleared Jul 14, 2006
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER
K061710
St Jude Medical
Cardiovascular · 25d
Cleared Jun 23, 2006
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
K060745
Asahi Intecc Co., Ltd.
Cardiovascular · 95d
Cleared Apr 27, 2006
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
K053491
Penumbra, Inc.
Cardiovascular · 133d
Cleared Apr 24, 2006
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
K060807
Biotronik, Inc.
Cardiovascular · 31d
Cleared Apr 12, 2006
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
K060327
Vascular Solutions, Inc.
Cardiovascular · 62d
Cleared Apr 04, 2006
SCOUTPRO 8F, MODELS 342 262
K060655
Biotronik, Inc.
Cardiovascular · 22d
Cleared Mar 15, 2006
8F SHERPA NX GUIDE CATHETER
K060418
Medtronic Vascular
Cardiovascular · 26d
Cleared Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K060572
Boston Scientific Corporation
Cardiovascular · 9d
Cleared Mar 08, 2006
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
K053217
St Jude Medical
Cardiovascular · 111d
Cleared Feb 24, 2006
CPS DIRECT SL OUTER CATHETER
K053277
St Jude Medical
Cardiovascular · 93d
Cleared Dec 16, 2005
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
K053116
Boston Scientific Corp
Cardiovascular · 39d
Cleared Dec 16, 2005
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
K053118
Boston Scientific Corp
Cardiovascular · 39d
Cleared Dec 13, 2005
VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER
K052258
Vascular Solutions, Inc.
Cardiovascular · 116d
Cleared Nov 23, 2005
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
K052257
Vascular Solutions, Inc.
Cardiovascular · 97d
Cleared Sep 26, 2005
ASAHI TORNUS SUPPORT CATHETER
K051772
Asahi Intecc Co., Ltd.
Cardiovascular · 88d
Cleared Sep 02, 2005
EDWARDS PERIPHERAL DILATION CATHETER
K052149
Edwards Lifesciences, LLC
Cardiovascular · 25d
Cleared Sep 01, 2005
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
K051838
Concentric Medical, Inc.
Cardiovascular · 56d
Cleared Aug 25, 2005
ATB ADVANCE PTA DILATATION CATHETER
K052036
Cook, Inc.
Cardiovascular · 28d
Cleared Aug 05, 2005
7F SHERPA NX GUIDE CATHETER
K051846
Medtronic Vascular
Cardiovascular · 29d
Cleared Jul 28, 2005
MINI GHOST PTA CATHETER, MODEL 507
K051343
NuMED, Inc.
Cardiovascular · 66d