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
337–360 of 895
Cleared Oct 27, 2011
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
K112917
Medtronic, Inc.
Cardiovascular · 24d
Cleared Oct 25, 2011
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
K112828
Codman & Shurtleff, Inc.
Cardiovascular · 27d
Cleared Oct 17, 2011
8FR TURBO - TANDEM SYSTEM
K112032
Spectranetics Corp.
Cardiovascular · 94d
Cleared Oct 12, 2011
BANTAM CATHETER (280MM BALLOON LENGTHS)
K112335
ClearStream Technologies , Ltd.
Cardiovascular · 61d
Cleared Oct 11, 2011
ONSET ACCESS CATHETER SYSTEM
K112629
Onset Medical Corporation
Cardiovascular · 32d
Cleared Oct 06, 2011
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
K112579
Avinger, Inc.
Cardiovascular · 30d
Cleared Sep 26, 2011
SELECTRA ACCESSORY KIT
K111839
Biotronik, Inc.
Cardiovascular · 89d
Cleared Sep 26, 2011
SELECTRA SLITTER TOOL
K112482
Biotronik, Inc.
Cardiovascular · 28d
Cleared Sep 13, 2011
THE UNBALLOON NON-OCCLUSIVE CATHETER
K110891
LeMaitre Vascular, Inc.
Cardiovascular · 167d
Cleared Sep 09, 2011
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX
K111704
Avinger, Inc.
Cardiovascular · 84d
Cleared Aug 17, 2011
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX
K112281
Trireme Medical, Inc.
Cardiovascular · 8d
Cleared Aug 10, 2011
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
K111963
Bridgepoint Medical
Cardiovascular · 30d
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 21, 2011
EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K111750
Angioslide, Ltd.
Cardiovascular · 29d
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 05, 2011
REVERSE MEDICAL REFLEX GUIDE CATHETER
K110055
Reverse Medical Corporation
Cardiovascular · 85d
Cleared Apr 04, 2011
MODIFIED HD GUIDE CATHETER
K110483
Concentric Medical, Inc.
Cardiovascular · 45d