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
Cleared
Jun 01, 2007
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610
Vascular Solutions, Inc.
Cardiovascular
113d
Cleared
May 11, 2007
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
St Jude Medical
Cardiovascular
155d
Cleared
Dec 15, 2006
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
Atrium Medical Corp.
Cardiovascular
183d
Cleared
Nov 17, 2006
ASAHI PRECIOUS GUIDE CATHETER
Asahi Intecc Co., Ltd.
Cardiovascular
162d
Cleared
Nov 14, 2006
ATB ADVANCED PTA DILATATION CATHETER
Cook, Inc.
Cardiovascular
18d
Cleared
Oct 25, 2006
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74
Medtronic Vascular
Cardiovascular
156d
Cleared
Oct 20, 2006
OCCLUSION BALLOON
Boston Scientific Corp
Cardiovascular
80d
Cleared
Oct 06, 2006
MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
AngioDynamics, Inc.
Cardiovascular
31d
Cleared
Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
Boston Scientific Corporation
Cardiovascular
19d
Cleared
Sep 08, 2006
5F SHERPA ACTIVE NX GUIDE CATHETER
Medtronic Vascular
Cardiovascular
21d
Cleared
Aug 09, 2006
CARDIODRIVE, MODEL 001-004115 (NON-STERILE)
Stereotaxis, Inc.
Cardiovascular
663d
Cleared
Aug 01, 2006
VENTURE WIRE CONTROL CATHETER, MODEL WCC
St Jude Medical
Cardiovascular
32d
Cleared
Jul 14, 2006
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER
St Jude Medical
Cardiovascular
25d
Cleared
Jun 23, 2006
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
Asahi Intecc Co., Ltd.
Cardiovascular
95d
Cleared
Apr 27, 2006
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
Penumbra, Inc.
Cardiovascular
133d
Cleared
Apr 24, 2006
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
Biotronik, Inc.
Cardiovascular
31d
Cleared
Apr 12, 2006
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
Vascular Solutions, Inc.
Cardiovascular
62d
Cleared
Apr 04, 2006
SCOUTPRO 8F, MODELS 342 262
Biotronik, Inc.
Cardiovascular
22d
Cleared
Mar 15, 2006
8F SHERPA NX GUIDE CATHETER
Medtronic Vascular
Cardiovascular
26d
Cleared
Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
Boston Scientific Corporation
Cardiovascular
9d
Cleared
Mar 08, 2006
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
St Jude Medical
Cardiovascular
111d
Cleared
Feb 24, 2006
CPS DIRECT SL OUTER CATHETER
St Jude Medical
Cardiovascular
93d
Cleared
Dec 16, 2005
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
Boston Scientific Corp
Cardiovascular
39d
Cleared
Dec 16, 2005
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
Boston Scientific Corp
Cardiovascular
39d