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
361–384 of 895
Cleared Feb 11, 2011
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
K103386
Medtronic, Inc.
Cardiovascular · 85d
Cleared Jan 19, 2011
CPS DIRECT SL II SLITTABLE OUTER CATHETER
K103250
St. Jude Medical, Cardiac Rhythm Management Divisi
Cardiovascular · 77d
Cleared Jan 05, 2011
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
K103534
Trireme Medical, Inc.
Cardiovascular · 35d
Cleared Dec 16, 2010
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
K101659
Vascular Solutions, Inc.
Cardiovascular · 188d
Cleared Dec 08, 2010
SEEKER CROSSING SUPPORT CATHETER
K103367
Bard Peripheral Vascular, Inc.
Cardiovascular · 22d
Cleared Nov 17, 2010
CONCENTRIC BALLOON GUIDE CATHETER
K102657
Concentric Medical, Inc.
Cardiovascular · 63d
Cleared Sep 23, 2010
GUIDE CATHETERS AND ACCESSORIES
K101015
Thomas Medical Products, Inc.
Cardiovascular · 164d
Cleared Sep 09, 2010
MEDTRONIC C315 DELIVERY CATHETER
K101885
Medtronic, Inc.
Cardiovascular · 65d
Cleared Aug 06, 2010
HEADWAY 17 ADVANCED MICROCATHETER
K101542
MicroVention, Inc.
Cardiovascular · 64d
Cleared Aug 06, 2010
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500
K101647
Avinger, Inc.
Cardiovascular · 56d
Cleared Aug 06, 2010
OCCLUSION BALLOON CATHETER MODEL OBC
K101877
Cook, Inc.
Cardiovascular · 31d
Cleared Aug 06, 2010
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S
K102022
Avinger, Inc.
Cardiovascular · 18d
Cleared Jul 23, 2010
SCOUTPRO ACS
K101776
Biotronik, Inc.
Cardiovascular · 28d
Cleared Jul 21, 2010
SCOUTPRO HEMOSTATIC VALVE
K101282
Biotronik, Inc.
Cardiovascular · 76d
Cleared Jul 16, 2010
LEV-OR DILATION CATHETER OTW
K101117
Baylis Medical Co., Inc.
Cardiovascular · 86d
Cleared Jul 13, 2010
PENUMBRA CATHERER 025
K100826
Penumbra, Inc.
Cardiovascular · 111d
Cleared Apr 20, 2010
CLEARWAY OTW MODEL 85912
K093431
Atrium Medical Corp.
Cardiovascular · 167d
Cleared Mar 05, 2010
ACUITY BREAK-AWAY GUIDE CATHETER
K093969
Cardiac Pacemakers, Inc.
Cardiovascular · 72d
Cleared Feb 26, 2010
ASAHI ZENYTEEX GUIDING CATHETER
K091188
Asahi Intecc Co., Ltd.
Cardiovascular · 309d
Cleared Dec 18, 2009
ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
K093050
Arrow Intl., Inc.
Cardiovascular · 79d
Cleared Nov 20, 2009
SCOUTPRO 7F LONG CATHETERS
K093303
Biotronik, Inc.
Cardiovascular · 30d
Cleared Nov 06, 2009
ENVOY GUIDING CATHETERS
K093184
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Nov 05, 2009
MODIFICATION TO MODIFIED HD GUIDE CATHETER
K092298
Concentric Medical, Inc.
Cardiovascular · 99d
Cleared Nov 05, 2009
HEADWAY 21 MICROCATHETER, MODEL: MC212150S
K093160
MicroVention, Inc.
Cardiovascular · 30d