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..

893
Total
893
Cleared
104d
Avg days
1979
Since
893 devices
385–408 of 893
Cleared May 02, 2002
EASYTRAK GUIDING CATHETER
K021284
Guidant Corp.
Cardiovascular · 14d
Cleared Apr 25, 2002
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
K013517
Medtronic Vascular
Cardiovascular · 185d
Cleared Feb 28, 2002
MODEL 9210 DELIVERY CATHETER, MODEL 9210
K013963
Medtronic Vascular
Cardiovascular · 87d
Cleared Feb 22, 2002
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
K020161
Guidant Corp.
Cardiovascular · 36d
Cleared Jan 22, 2002
6F MACH1/34356-XXX
K020028
Boston Scientific
Cardiovascular · 18d
Cleared Jan 17, 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212
C.R. Bard, Inc.
Cardiovascular · 27d
Cleared Jan 03, 2002
NUMED MULLINS PTA CATHETER
K013601
NuMED, Inc.
Cardiovascular · 64d
Cleared Dec 21, 2001
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889
Boston Scientific Corp
Cardiovascular · 186d
Cleared Dec 04, 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638
Guidant Corp.
Cardiovascular · 29d
Cleared Nov 21, 2001
STENT SUPPORT GUIDE CATHETER
K010579
Medtronic Vascular
Cardiovascular · 267d
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 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 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