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
241–264 of 895
Cleared May 12, 2015
Coda LP Balloon Catheter
K150970
Cook Incorporated
Cardiovascular · 29d
Cleared May 04, 2015
NovaCross Microcatheter
K143608
Nitiloop , Ltd.
Cardiovascular · 136d
Cleared Apr 14, 2015
MicroCross Catheter
K143744
Roxwood Medical, Inc.
Cardiovascular · 104d
Cleared Apr 01, 2015
Silk Road Acccess Catheter
K143459
Silk Road Medical, Inc.
Cardiovascular · 118d
Cleared Mar 27, 2015
SOFIA 6F Catheter
K150366
MicroVention, Inc.
Cardiovascular · 43d
Cleared Mar 26, 2015
Headway 27 Microcatheter
K142449
MicroVention, Inc.
Cardiovascular · 205d
Cleared Mar 09, 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
K141981
Asahi Intecc Co., Ltd.
Cardiovascular · 231d
Cleared Feb 27, 2015
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
K150201
Spectranetics, Inc.
Cardiovascular · 29d
Cleared Jan 30, 2015
NAVAJO PTA BALLOON DILATATION CATHETER
K141354
Curative Medical, Inc.
Cardiovascular · 252d
Cleared Jan 26, 2015
Benchmark Intracranial Access System
K142321
Penumbra, Inc.
Cardiovascular · 160d
Cleared Jan 14, 2015
ADROIT Guiding Catheter
K143412
Cordis Corporation
Cardiovascular · 47d
Cleared Dec 18, 2014
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
K142235
St Jude Medical
Cardiovascular · 127d
Cleared Dec 18, 2014
CPS Direct MediGuide Enabled outer catheter
K142239
St Jude Medical
Cardiovascular · 127d
Cleared Dec 03, 2014
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
K141529
Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
Cardiovascular · 177d
Cleared Nov 25, 2014
TURNPIKE CATHETER
K142065
Vascular Solutions, Inc.
Cardiovascular · 118d
Cleared Nov 19, 2014
CENTERCROSS CATHETER
K140910
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
K142565
Stryker Neurovascular
Cardiovascular · 63d
Cleared Nov 05, 2014
SPEX SUPPORT CATHETER
K141649
Reflow Medical
Cardiovascular · 138d
Cleared Oct 10, 2014
SOFIA DISTAL ACCESS CATHETER
K142014
MicroVention, Inc.
Cardiovascular · 78d
Cleared Sep 30, 2014
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K141547
Reflow Medical
Cardiovascular · 111d
Cleared Sep 18, 2014
MIVI 6F GUIDE CATHETER
K140557
Mivi, LLC
Cardiovascular · 197d
Cleared Apr 24, 2014
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
K140080
Codman & Shurtleff, Inc.
Cardiovascular · 100d
Cleared Apr 21, 2014
ENVOY GUIDING CATHETER
K140307
Codman & Shurtleff, Inc.
Cardiovascular · 73d
Cleared Apr 03, 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914
Boston Scientific
Cardiovascular · 198d