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
Cleared
Oct 22, 2003
PTA BALLOON CATHETER
Cook, Inc.
Cardiovascular
30d
Cleared
Oct 21, 2003
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
Medtronic Vascular
Cardiovascular
85d
Cleared
Oct 02, 2003
EDWARDS PERIPHERAL DILATATION CATHETER
Edwards Lifesciences, LLC
Cardiovascular
41d
Cleared
Sep 25, 2003
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
NuMED, Inc.
Cardiovascular
34d
Cleared
Sep 03, 2003
EDWARDS DIRECTIONAL CATHETER
Edwards Lifesciences, LLC
Cardiovascular
188d
Cleared
Sep 03, 2003
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
Medtronic Vascular
Cardiovascular
8d
Cleared
Aug 27, 2003
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
AngioDynamics, Inc.
Cardiovascular
55d
Cleared
Aug 22, 2003
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
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
Medtronic Vascular
Cardiovascular
150d
Cleared
Jul 23, 2003
RAPIDO CUT-AWAY CUTTER
Guidant Corp.
Cardiovascular
76d
Cleared
Jul 17, 2003
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
Medtronic Vascular
Cardiovascular
91d
Cleared
Jul 11, 2003
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
Intra Luminal Therapeutics, Inc.
Cardiovascular
67d
Cleared
Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
Cook, Inc.
Cardiovascular
17d
Cleared
May 21, 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
NuMED, Inc.
Cardiovascular
85d
Cleared
Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
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
Intra Luminal Therapeutics, Inc.
Cardiovascular
27d
Cleared
Apr 08, 2003
STEREOTAXIS CATHETER ADVANCER SYSTEM
Stereotaxis, Inc.
Cardiovascular
309d
Cleared
Mar 11, 2003
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
Concentric Medical, Inc.
Cardiovascular
26d
Cleared
Dec 30, 2002
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
Medtronic Vascular
Cardiovascular
24d
Cleared
Dec 30, 2002
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
Medtronic Vascular
Cardiovascular
24d
Cleared
Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
Guidant Corp.
Cardiovascular
67d
Cleared
Nov 06, 2002
8F LAUNCHER GUIDE CATHETER
Medtronic Vascular
Cardiovascular
27d
Cleared
Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
Cook, Inc.
Cardiovascular
56d
Cleared
Sep 23, 2002
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
Spectranetics Corp.
Cardiovascular
83d