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
481–504 of 895
Cleared Dec 13, 2004
6F Z4 GUIDE CATHETER
K042489
Medtronic Vascular
Cardiovascular · 90d
Cleared Nov 22, 2004
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K042910
Velocimed, Inc.
Cardiovascular · 32d
Cleared Nov 08, 2004
SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX
K042537
Invatec Innovative Technologies
Cardiovascular · 49d
Cleared Nov 08, 2004
SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX
K042538
Invatec Innovative Technologies
Cardiovascular · 49d
Cleared Nov 05, 2004
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
K042230
Cryo Vascular Systems, Inc.
Cardiovascular · 80d
Cleared Oct 28, 2004
RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
K042388
Radiant Medical
Cardiovascular · 56d
Cleared Oct 15, 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568
Boston Scientific Corp
Cardiovascular · 24d
Cleared Oct 12, 2004
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K042541
Cryo Vascular Systems, Inc.
Cardiovascular · 22d
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 Jul 22, 2004
KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
K041151
Kerberos Proximal Solutions, Inc.
Cardiovascular · 80d
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 Mar 18, 2004
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
K040481
Intra Luminal Therapeutics, Inc.
Cardiovascular · 22d
Cleared Feb 23, 2004
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038
K033678
Spectranetics Corp.
Cardiovascular · 91d
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 Nov 18, 2003
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K032784
Intra Luminal Therapeutics, Inc.
Cardiovascular · 71d
Cleared Oct 31, 2003
PHERON PTA CATHETER
K033217
Biotronik, Inc.
Cardiovascular · 28d