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
Cleared
Mar 26, 2015
Headway 27 Microcatheter
MicroVention, Inc.
Cardiovascular
205d
Cleared
Mar 09, 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
Asahi Intecc Co., Ltd.
Cardiovascular
231d
Cleared
Jan 26, 2015
Benchmark Intracranial Access System
Penumbra, Inc.
Cardiovascular
160d
Cleared
Dec 18, 2014
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
St Jude Medical
Cardiovascular
127d
Cleared
Dec 18, 2014
CPS Direct MediGuide Enabled outer catheter
St Jude Medical
Cardiovascular
127d
Cleared
Nov 25, 2014
TURNPIKE CATHETER
Vascular Solutions, Inc.
Cardiovascular
118d
Cleared
Oct 10, 2014
SOFIA DISTAL ACCESS CATHETER
MicroVention, Inc.
Cardiovascular
78d
Cleared
Apr 24, 2014
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
Codman & Shurtleff, Inc.
Cardiovascular
100d
Cleared
Apr 21, 2014
ENVOY GUIDING CATHETER
Codman & Shurtleff, Inc.
Cardiovascular
73d
Cleared
Apr 03, 2014
ACUITY PRO LEAD DELIVERY SYSTEM
Boston Scientific
Cardiovascular
198d
Cleared
Mar 26, 2014
TOTAL ACROSS
Medtronic Vascular
Cardiovascular
128d
Cleared
Feb 25, 2014
MODIFIED HD GUIDE CATHETER
Concentric Medical, Inc.
Cardiovascular
131d
Cleared
Feb 25, 2014
LEADLINER CS LEAD DELIVERY SYSTEM
Vascular Solutions, Inc.
Cardiovascular
103d
Cleared
Jan 29, 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
Cook, Inc.
Cardiovascular
275d
Cleared
Nov 22, 2013
SOFIA DISTAL ACCESS CATHETER
MicroVention, Inc.
Cardiovascular
183d
Cleared
Oct 24, 2013
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
Asahi Intecc Co., Ltd.
Cardiovascular
71d
Cleared
Oct 22, 2013
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
Medtronic, Inc.
Cardiovascular
56d
Cleared
Oct 03, 2013
MODIFIED FLOWGATE BALLOON GUIDE CATHETER
Concentric Medical, Inc.
Cardiovascular
133d
Cleared
Sep 27, 2013
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
Volcano Corporation
Cardiovascular
32d
Cleared
Aug 29, 2013
CONCIERGE GUIDING CATHETER
Merit Medical Systems, Inc.
Cardiovascular
27d
Cleared
Aug 23, 2013
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
Biotronik, Inc.
Cardiovascular
56d
Cleared
Aug 15, 2013
AMPLATZER TORQ VUE LP DELIVERY SYSTEM
St Jude Medical
Cardiovascular
121d
Cleared
Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
C.R. Bard, Inc.
Cardiovascular
71d
Cleared
Jun 28, 2013
CODA BALLOON CATHETER
Cook, Inc.
Cardiovascular
276d