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
May 12, 2015
Coda LP Balloon Catheter
Cook Incorporated
Cardiovascular
29d
Cleared
May 04, 2015
NovaCross Microcatheter
Nitiloop , Ltd.
Cardiovascular
136d
Cleared
Apr 14, 2015
MicroCross Catheter
Roxwood Medical, Inc.
Cardiovascular
104d
Cleared
Apr 01, 2015
Silk Road Acccess Catheter
Silk Road Medical, Inc.
Cardiovascular
118d
Cleared
Mar 27, 2015
SOFIA 6F Catheter
MicroVention, Inc.
Cardiovascular
43d
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
Feb 27, 2015
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
Spectranetics, Inc.
Cardiovascular
29d
Cleared
Jan 30, 2015
NAVAJO PTA BALLOON DILATATION CATHETER
Curative Medical, Inc.
Cardiovascular
252d
Cleared
Jan 26, 2015
Benchmark Intracranial Access System
Penumbra, Inc.
Cardiovascular
160d
Cleared
Jan 14, 2015
ADROIT Guiding Catheter
Cordis Corporation
Cardiovascular
47d
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
Dec 03, 2014
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
Cardiovascular
177d
Cleared
Nov 25, 2014
TURNPIKE CATHETER
Vascular Solutions, Inc.
Cardiovascular
118d
Cleared
Nov 19, 2014
CENTERCROSS CATHETER
Roxwood Medical, Inc.
Cardiovascular
224d
Cleared
Nov 14, 2014
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter
Stryker Neurovascular
Cardiovascular
63d
Cleared
Nov 05, 2014
SPEX SUPPORT CATHETER
Reflow Medical
Cardiovascular
138d
Cleared
Oct 10, 2014
SOFIA DISTAL ACCESS CATHETER
MicroVention, Inc.
Cardiovascular
78d
Cleared
Sep 30, 2014
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
Reflow Medical
Cardiovascular
111d
Cleared
Sep 18, 2014
MIVI 6F GUIDE CATHETER
Mivi, LLC
Cardiovascular
197d
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