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, Cordis Corp. and C.R. Bard, Inc..

889
Total
889
Cleared
104d
Avg days
1979
Since
889 devices
193–216 of 889
Cleared Mar 15, 2006
8F SHERPA NX GUIDE CATHETER
K060418
Medtronic Vascular
Cardiovascular · 26d
Cleared Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K060572
Boston Scientific Corporation
Cardiovascular · 9d
Cleared Dec 16, 2005
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX
K053116
Boston Scientific Corp
Cardiovascular · 39d
Cleared Dec 16, 2005
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
K053118
Boston Scientific Corp
Cardiovascular · 39d
Cleared Aug 05, 2005
7F SHERPA NX GUIDE CATHETER
K051846
Medtronic Vascular
Cardiovascular · 29d
Cleared Jun 03, 2005
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
K050599
Boston Scientific Corp
Cardiovascular · 86d
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 May 25, 2004
TRANSXCHANGE SUPPORT CATHETER
K033540
Medtronic Vascular
Cardiovascular · 197d
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 Oct 21, 2003
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K032312
Medtronic Vascular
Cardiovascular · 85d
Cleared Sep 03, 2003
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
K032622
Medtronic Vascular
Cardiovascular · 8d
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 17, 2003
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
K031211
Medtronic Vascular
Cardiovascular · 91d
Cleared Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779
Medtronic Vascular
Cardiovascular · 44d
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 Nov 06, 2002
8F LAUNCHER GUIDE CATHETER
K023402
Medtronic Vascular
Cardiovascular · 27d
Cleared Aug 28, 2002
7F LAUNCHER GUIDE CATHETER
K022764
Medtronic Vascular
Cardiovascular · 7d
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