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 Vascular Solutions, Inc..

893
Total
893
Cleared
104d
Avg days
1979
Since
893 devices
193–216 of 893
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 Jan 26, 2015
Benchmark Intracranial Access System
K142321
Penumbra, Inc.
Cardiovascular · 160d
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 Nov 25, 2014
TURNPIKE CATHETER
K142065
Vascular Solutions, Inc.
Cardiovascular · 118d
Cleared Oct 10, 2014
SOFIA DISTAL ACCESS CATHETER
K142014
MicroVention, Inc.
Cardiovascular · 78d
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
Cleared Mar 26, 2014
TOTAL ACROSS
K133539
Medtronic Vascular
Cardiovascular · 128d
Cleared Feb 25, 2014
MODIFIED HD GUIDE CATHETER
K133177
Concentric Medical, Inc.
Cardiovascular · 131d
Cleared Feb 25, 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501
Vascular Solutions, Inc.
Cardiovascular · 103d
Cleared Jan 29, 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204
Cook, Inc.
Cardiovascular · 275d
Cleared Nov 22, 2013
SOFIA DISTAL ACCESS CATHETER
K131482
MicroVention, Inc.
Cardiovascular · 183d
Cleared Oct 24, 2013
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
K132556
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
K132673
Medtronic, Inc.
Cardiovascular · 56d
Cleared Oct 03, 2013
MODIFIED FLOWGATE BALLOON GUIDE CATHETER
K131492
Concentric Medical, Inc.
Cardiovascular · 133d
Cleared Sep 27, 2013
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
K132659
Volcano Corporation
Cardiovascular · 32d
Cleared Aug 29, 2013
CONCIERGE GUIDING CATHETER
K132409
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Aug 23, 2013
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
K131978
Biotronik, Inc.
Cardiovascular · 56d
Cleared Aug 15, 2013
AMPLATZER TORQ VUE LP DELIVERY SYSTEM
K131063
St Jude Medical
Cardiovascular · 121d
Cleared Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493
C.R. Bard, Inc.
Cardiovascular · 71d
Cleared Jun 28, 2013
CODA BALLOON CATHETER
K122917
Cook, Inc.
Cardiovascular · 276d