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
553–576 of 895
Cleared Oct 09, 2001
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
K010954
Concentric Medical, Inc.
Cardiovascular · 193d
Cleared Sep 28, 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Sep 06, 2001
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
K012050
Guidant Corp.
Cardiovascular · 66d
Cleared Aug 30, 2001
ILT SUPPORT CATHETER .014, MODEL C114LW1
K012169
Intra Luminal Therapeutics, Inc.
Cardiovascular · 49d
Cleared Aug 28, 2001
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K012083
Medtronic Vascular
Cardiovascular · 56d
Cleared Aug 28, 2001
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
K012130
Medtronic Vascular
Cardiovascular · 50d
Cleared Jul 26, 2001
VIKING OPTIMA GUIDING CATHETER
K012002
Guidant Corp.
Cardiovascular · 29d
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874
Boston Scientific Corp
Cardiovascular · 90d
Cleared Jun 15, 2001
CORDIS M3 PTA DILATATION CATHETER
K003920
Cordis Corp.
Cardiovascular · 178d
Cleared Jun 13, 2001
AVIATOR PERIPHERAL DILATATION CATHETER
K010831
Guidant Corp.
Cardiovascular · 85d
Cleared May 22, 2001
CONCENTRIC RETRIEVER, MODEL 90030
K003410
Concentric Medical, Inc.
Cardiovascular · 201d
Cleared May 16, 2001
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
K003880
Concentric Medical, Inc.
Cardiovascular · 152d
Cleared Apr 20, 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880
NuMED, Inc.
Cardiovascular · 28d
Cleared Apr 18, 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
K010531
Intra Luminal Therapeutics, Inc.
Cardiovascular · 54d
Cleared Apr 18, 2001
GUIDER SOFTIP GUIDING CATHETER XF 5F
K010853
Boston Scientific, Target
Cardiovascular · 28d
Cleared Mar 07, 2001
SUPERCROSS CATHETER
K001856
Abbott Vascular, Inc.
Cardiovascular · 261d
Cleared Mar 07, 2001
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
K003085
Concentric Medical, Inc.
Cardiovascular · 155d
Cleared Feb 13, 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169
C.R. Bard, Inc.
Cardiovascular · 26d
Cleared Dec 27, 2000
NUMED Z-MED PTV CATHERERS
K003643
NuMED, Inc.
Cardiovascular · 30d
Cleared Sep 25, 2000
ILT 0.014 CATHETER, MODEL C114NL2
K001992
Intra Luminal Therapeutics, Inc.
Cardiovascular · 88d
Cleared Aug 16, 2000
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969
Medtronic Vascular
Cardiovascular · 49d
Cleared Jun 02, 2000
VIKING OPTIMA GUIDING CATHETER
K001435
Guidant Corp.
Cardiovascular · 25d
Cleared Apr 28, 2000
CORDIS INTRODUCER GUIDE
K001136
Cordis Corp.
Cardiovascular · 18d
Cleared Mar 31, 2000
ENVOY AND VISTA BRITE TIP
K000715
Cordis Corp.
Cardiovascular · 29d