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 Vascular Solutions, Inc..

893
Total
893
Cleared
104d
Avg days
1979
Since
893 devices
337–360 of 893
Cleared Jun 03, 2005
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
K050599
Boston Scientific Corp
Cardiovascular · 86d
Cleared May 26, 2005
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K051060
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared May 25, 2005
ULTRA-SOFT SV BALLOON DILATATION CATHETER
K050389
Boston Scientific Corp
Cardiovascular · 99d
Cleared Dec 13, 2004
6F Z4 GUIDE CATHETER
K042489
Medtronic Vascular
Cardiovascular · 90d
Cleared Oct 15, 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568
Boston Scientific Corp
Cardiovascular · 24d
Cleared Sep 15, 2004
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
K042194
Medtronic Vascular
Cardiovascular · 34d
Cleared Aug 11, 2004
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
K040745
Concentric Medical, Inc.
Cardiovascular · 141d
Cleared Jun 21, 2004
CONCENTRIC RETRIEVER X5, MODEL 90035
K040700
Concentric Medical, Inc.
Cardiovascular · 96d
Cleared May 25, 2004
TRANSXCHANGE SUPPORT CATHETER
K033540
Medtronic Vascular
Cardiovascular · 197d
Cleared May 06, 2004
NUMED MULLINS X PTA CATHETER
K041093
NuMED, Inc.
Cardiovascular · 9d
Cleared May 05, 2004
GORE TRI-LOBE BALLOON CATHETER
K033670
W.L. Gore & Associates, Inc.
Cardiovascular · 163d
Cleared Apr 02, 2004
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K033875
Cook, Inc.
Cardiovascular · 109d
Cleared Feb 13, 2004
BARD ATLAS PTA BALLOON DILATATION CATHETER
K040243
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Nov 21, 2003
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
K033441
Boston Scientific Corp
Cardiovascular · 23d
Cleared Nov 19, 2003
COOK CODA BALLOON CATHETER
K032869
Cook, Inc.
Cardiovascular · 65d
Cleared Nov 19, 2003
SCOUT PRO
K033320
Biotronik, Inc.
Cardiovascular · 35d
Cleared Oct 31, 2003
PHERON PTA CATHETER
K033217
Biotronik, Inc.
Cardiovascular · 28d
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