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
505–528 of 895
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931
Cook, Inc.
Cardiovascular · 30d
Cleared Oct 21, 2003
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K032312
Medtronic Vascular
Cardiovascular · 85d
Cleared Oct 02, 2003
EDWARDS PERIPHERAL DILATATION CATHETER
K032587
Edwards Lifesciences, LLC
Cardiovascular · 41d
Cleared Sep 25, 2003
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
K032591
NuMED, Inc.
Cardiovascular · 34d
Cleared Sep 03, 2003
EDWARDS DIRECTIONAL CATHETER
K030630
Edwards Lifesciences, LLC
Cardiovascular · 188d
Cleared Sep 03, 2003
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
K032622
Medtronic Vascular
Cardiovascular · 8d
Cleared Aug 27, 2003
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K032069
AngioDynamics, Inc.
Cardiovascular · 55d
Cleared Aug 22, 2003
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K031692
Intra Luminal Therapeutics, Inc.
Cardiovascular · 81d
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 Jul 11, 2003
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
K031417
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
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 Apr 24, 2003
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT
K030984
Intra Luminal Therapeutics, Inc.
Cardiovascular · 27d
Cleared Apr 08, 2003
STEREOTAXIS CATHETER ADVANCER SYSTEM
K021802
Stereotaxis, Inc.
Cardiovascular · 309d
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 23, 2002
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
K022138
Spectranetics Corp.
Cardiovascular · 83d