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
241–264 of 893
Cleared Sep 26, 2011
SELECTRA SLITTER TOOL
K112482
Biotronik, Inc.
Cardiovascular · 28d
Cleared Aug 05, 2011
HEADWAY 27 MICROCATHETER
K110813
MicroVention, Inc.
Cardiovascular · 134d
Cleared Aug 01, 2011
BENELLI ACCESS DEVICE
K111334
Vascular Solutions, Inc.
Cardiovascular · 81d
Cleared Jul 29, 2011
GLIDECROSS SUPPORT CATHETER
K111556
Terumo Medical Corp.
Cardiovascular · 53d
Cleared Jul 19, 2011
NEURON MAX SYSTEM
K111380
Penumbra, Inc.
Cardiovascular · 64d
Cleared Jul 13, 2011
VACCESS PTA DILATATION CATHETER
K111850
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Jun 02, 2011
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
K111252
Boston Scientific Corp
Cardiovascular · 30d
Cleared May 23, 2011
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
K111154
Biotronik, Inc.
Cardiovascular · 28d
Cleared May 13, 2011
TERUMO SUPPORT CATHETER
K110540
Terumo Medical Corp.
Cardiovascular · 77d
Cleared Apr 20, 2011
SELECTRA CS LEAD INTRODUCER SYSTEM
K110461
Biotronik, Inc.
Cardiovascular · 62d
Cleared Apr 04, 2011
MODIFIED HD GUIDE CATHETER
K110483
Concentric Medical, Inc.
Cardiovascular · 45d
Cleared Feb 11, 2011
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
K103386
Medtronic, Inc.
Cardiovascular · 85d
Cleared Dec 16, 2010
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
K101659
Vascular Solutions, Inc.
Cardiovascular · 188d
Cleared Nov 17, 2010
CONCENTRIC BALLOON GUIDE CATHETER
K102657
Concentric Medical, Inc.
Cardiovascular · 63d
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
OCCLUSION BALLOON CATHETER MODEL OBC
K101877
Cook, Inc.
Cardiovascular · 31d
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 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