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
529–552 of 895
Cleared Sep 13, 2002
PTA AND PTV
K022722
NuMED, Inc.
Cardiovascular · 28d
Cleared Sep 13, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K022738
Guidant Corp.
Cardiovascular · 25d
Cleared Aug 28, 2002
7F LAUNCHER GUIDE CATHETER
K022764
Medtronic Vascular
Cardiovascular · 7d
Cleared Aug 08, 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735
Boston Scientific Scimed, Inc.
Cardiovascular · 72d
Cleared Aug 02, 2002
RAPIDO GUIDING CATHETER, 6F MODEL# 6776
K021455
Guidant Corp.
Cardiovascular · 88d
Cleared Jul 10, 2002
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
K021899
Concentric Medical, Inc.
Cardiovascular · 30d
Cleared Jun 20, 2002
EQUALIZER BALLOON CATHETER
K021721
Boston Scientific Corp
Cardiovascular · 27d
Cleared Jun 13, 2002
MODIFICATION TO ENVOY AND VISTA BRITE TIP
K021593
Cordis Corp.
Cardiovascular · 29d
Cleared May 30, 2002
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
K021587
Medtronic Vascular
Cardiovascular · 15d
Cleared May 30, 2002
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K021589
Medtronic Vascular
Cardiovascular · 15d
Cleared May 17, 2002
Z3 GUIDE CATHETER
K021256
Medtronic Vascular
Cardiovascular · 28d
Cleared May 02, 2002
RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP
K021120
Arrow Intl., Inc.
Cardiovascular · 24d
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 11, 2002
MODIFICATION TO SUPERCROSS CATHETER
K014118
Abbott Vascular, Inc.
Cardiovascular · 28d
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 06, 2001
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
K013789
Boston Scientific, Target
Cardiovascular · 22d
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