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
361–384 of 893
Cleared Jul 31, 2003
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB
K030671
Medtronic Vascular
Cardiovascular · 150d
Cleared Jul 23, 2003
RAPIDO CUT-AWAY CUTTER
K031459
Guidant Corp.
Cardiovascular · 76d
Cleared Jul 17, 2003
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
K031211
Medtronic Vascular
Cardiovascular · 91d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766
Cook, Inc.
Cardiovascular · 17d
Cleared May 21, 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589
NuMED, Inc.
Cardiovascular · 85d
Cleared Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779
Medtronic Vascular
Cardiovascular · 44d
Cleared Mar 11, 2003
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
K030476
Concentric Medical, Inc.
Cardiovascular · 26d
Cleared Dec 30, 2002
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024032
Medtronic Vascular
Cardiovascular · 24d
Cleared Dec 30, 2002
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024035
Medtronic Vascular
Cardiovascular · 24d
Cleared Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K023320
Guidant Corp.
Cardiovascular · 67d
Cleared Nov 06, 2002
8F LAUNCHER GUIDE CATHETER
K023402
Medtronic Vascular
Cardiovascular · 27d
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552
Cook, Inc.
Cardiovascular · 56d
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