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
313–336 of 895
Cleared Aug 15, 2012
ARMADA 14XXT PTA CATHETER
K121352
Abbott Vascular
Cardiovascular · 103d
Cleared Aug 09, 2012
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
K120781
Fuji Systems Corp.
Cardiovascular · 147d
Cleared Aug 08, 2012
CONVEY GUIDING CATHETER
K120585
Pendracare International, B.V.
Cardiovascular · 163d
Cleared Aug 08, 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K121839
LeMaitre Vascular, Inc.
Cardiovascular · 47d
Cleared Jun 13, 2012
CONCIERGE GUIDING CATHETER
K121051
Merit Medical Systems, Inc.
Cardiovascular · 68d
Cleared May 25, 2012
UPSTREAM GR CATHETER
K120964
Upstream Peripheral Technologies
Cardiovascular · 56d
Cleared May 15, 2012
SWITCH-IT CATHETER
K120707
Vascular Solutions, Inc.
Cardiovascular · 68d
Cleared May 11, 2012
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
K120296
St. Jude Medical, Cardiac Rhythm Management Divisi
Cardiovascular · 101d
Cleared Apr 20, 2012
EXCELSIOR XT-27 MICROCATHETER
K113778
Stryker Neurovascular
Cardiovascular · 120d
Cleared Mar 20, 2012
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
K112100
Vascular Solutions, Inc.
Cardiovascular · 242d
Cleared Mar 15, 2012
CONCENTRIC BALLOON GUIDE CATHETER
K112404
Concentric Medical, Inc.
Cardiovascular · 206d
Cleared Mar 15, 2012
AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH
K120120
Aga Medical Corporation
Cardiovascular · 58d
Cleared Feb 24, 2012
ENVOY DISTAL ACCESS GUIDING CATHETER
K120229
Codman & Shurtleff, Inc.
Cardiovascular · 30d
Cleared Feb 24, 2012
Q50 PLUS STENT GRAFT BALLOON CATHETER
K120381
Qxmedical, LLC
Cardiovascular · 17d
Cleared Feb 23, 2012
UPSTREAM SUPPORT CATHETER
K112886
Upstream Peripheral Technologies
Cardiovascular · 146d
Cleared Feb 08, 2012
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K120178
Reflow Medical
Cardiovascular · 19d
Cleared Feb 03, 2012
MANTARAY CATHETER
K120129
Bridgepoint Medical
Cardiovascular · 17d
Cleared Jan 05, 2012
VALET MICRO CATHETER
K112035
Volcano Corporation
Cardiovascular · 174d
Cleared Jan 04, 2012
BIGBOSS CATHETER
K113589
Bridgepoint Medical
Cardiovascular · 30d
Cleared Dec 14, 2011
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)
K111738
Trireme Medical, Inc.
Cardiovascular · 176d
Cleared Dec 01, 2011
GUIDELINER V2 CATHETER
K112082
Vascular Solutions, Inc.
Cardiovascular · 133d
Cleared Nov 17, 2011
CLEARWAY RX NB CATHETER
K113112
Atrium Medical Corp.
Cardiovascular · 28d
Cleared Nov 09, 2011
RUBICON SUPPORT CATHETER
K112303
Boston Scientific
Cardiovascular · 90d
Cleared Nov 02, 2011
REFLEX BALLON GUIDE CATHETER
K112262
Reverse Medical Corporation
Cardiovascular · 86d