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
289–312 of 893
Cleared Nov 20, 2008
EVERCROSS .035 OTW PTA DILATATION CATHETER
K082579
Ev3, Inc.
Cardiovascular · 76d
Cleared Nov 03, 2008
PASSEO-35 PTA CATHETER
K082933
Biotronik, Inc.
Cardiovascular · 33d
Cleared Oct 31, 2008
NEURON DELIVERY CATHETER 070
K082290
Penumbra, Inc.
Cardiovascular · 81d
Cleared Oct 24, 2008
MULLINS-X, MODEL 250X
K082868
NuMED, Inc.
Cardiovascular · 25d
Cleared Oct 03, 2008
GORE TRI-LOBE BALLOON CATHETER
K081799
W.L. Gore & Associates, Inc.
Cardiovascular · 100d
Cleared Sep 26, 2008
MINI GHOST, MODEL: 507
K082524
NuMED, Inc.
Cardiovascular · 24d
Cleared Jul 18, 2008
MODIFIED HD GUIDE CATHETER
K080583
Concentric Medical, Inc.
Cardiovascular · 137d
Cleared Jul 10, 2008
NUCLEUS-X, MODEL 230X
K081680
NuMED, Inc.
Cardiovascular · 23d
Cleared May 07, 2008
SCOUTPRO CS LEAD INTRODUCER SYSTEM
K080988
Biotronik, Inc.
Cardiovascular · 30d
Cleared Mar 25, 2008
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
K072329
Biotronik, Inc.
Cardiovascular · 218d
Cleared Mar 20, 2008
ACUITY UNIVERSAL CUTTER
K080154
Cardiac Pacemakers, Inc.
Cardiovascular · 57d
Cleared Dec 28, 2007
ADVANCE 18LP PTA DILATATION CATHETER
K073378
Cook, Inc.
Cardiovascular · 25d
Cleared Nov 21, 2007
TWIN-PASS OTW CATHETER, MODEL 5201
K072618
Vascular Solutions, Inc.
Cardiovascular · 65d
Cleared Sep 17, 2007
PRECIOUS PLUS GUIDE CATHETER
K072316
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Aug 17, 2007
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
K070970
Penumbra, Inc.
Cardiovascular · 133d
Cleared Jul 18, 2007
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
K071665
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jun 13, 2007
STRIDE MICROCATHETER
K062885
Asahi Intecc Co., Ltd.
Cardiovascular · 260d
Cleared Jun 01, 2007
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610
K070372
Vascular Solutions, Inc.
Cardiovascular · 113d
Cleared May 11, 2007
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
K063638
St Jude Medical
Cardiovascular · 155d
Cleared Dec 15, 2006
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
K061680
Atrium Medical Corp.
Cardiovascular · 183d
Cleared Nov 17, 2006
ASAHI PRECIOUS GUIDE CATHETER
K061601
Asahi Intecc Co., Ltd.
Cardiovascular · 162d
Cleared Nov 14, 2006
ATB ADVANCED PTA DILATATION CATHETER
K063252
Cook, Inc.
Cardiovascular · 18d
Cleared Oct 25, 2006
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74
K061416
Medtronic Vascular
Cardiovascular · 156d
Cleared Oct 20, 2006
OCCLUSION BALLOON
K062202
Boston Scientific Corp
Cardiovascular · 80d