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 Cordis Corp..

895
Total
895
Cleared
104d
Avg days
1979
Since
895 devices
433–456 of 895
Cleared Jun 01, 2007
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610
K070372
Vascular Solutions, Inc.
Cardiovascular · 113d
Cleared May 11, 2007
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
K063638
St Jude Medical
Cardiovascular · 155d
Cleared Dec 15, 2006
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
K061680
Atrium Medical Corp.
Cardiovascular · 183d
Cleared Nov 17, 2006
ASAHI PRECIOUS GUIDE CATHETER
K061601
Asahi Intecc Co., Ltd.
Cardiovascular · 162d
Cleared Nov 14, 2006
ATB ADVANCED PTA DILATATION CATHETER
K063252
Cook, Inc.
Cardiovascular · 18d
Cleared Oct 25, 2006
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74
K061416
Medtronic Vascular
Cardiovascular · 156d
Cleared Oct 20, 2006
OCCLUSION BALLOON
K062202
Boston Scientific Corp
Cardiovascular · 80d
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 09, 2006
CARDIODRIVE, MODEL 001-004115 (NON-STERILE)
K042850
Stereotaxis, Inc.
Cardiovascular · 663d
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