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
385–408 of 895
Cleared Nov 04, 2009
GUIDELINER CATHETER, MODELS 5571, 5572, 5573
K091750
Vascular Solutions, Inc.
Cardiovascular · 141d
Cleared Sep 04, 2009
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
K092396
Spectranetics Corp.
Cardiovascular · 30d
Cleared Aug 07, 2009
TRAILBLAZER SUPPORT CATHETER
K092299
Ev3, Inc.
Cardiovascular · 9d
Cleared Jul 01, 2009
SPECTRANETICS TURBO-TANDEM SYSTEM
K091299
Spectranetics Corp.
Cardiovascular · 58d
Cleared Jun 18, 2009
PIGGYBACK WIRE CONVERTER
K090977
Vascular Solutions, Inc.
Cardiovascular · 73d
Cleared Jun 12, 2009
GOPHER GOLD CATHETER, MODEL 5620
K091345
Vascular Solutions, Inc.
Cardiovascular · 37d
Cleared Jun 12, 2009
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K091527
Cook, Inc.
Cardiovascular · 17d
Cleared May 06, 2009
HD GUIDE CATHETER
K090335
Concentric Medical, Inc.
Cardiovascular · 85d
Cleared May 04, 2009
CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K090913
Spectranetics Corp.
Cardiovascular · 33d
Cleared May 01, 2009
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
K090849
Ev3, Inc.
Cardiovascular · 32d
Cleared Apr 27, 2009
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
K090822
Cook, Inc.
Cardiovascular · 32d
Cleared Mar 26, 2009
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY
K090659
Medtronic, Inc.
Cardiovascular · 14d
Cleared Feb 06, 2009
6F TAIGA GUIDING CATHETER
K083422
Medtronic Vascular
Cardiovascular · 79d
Cleared Feb 03, 2009
ASAHI CORSAIR MICROCATHETER
K083127
Asahi Intecc Co., Ltd.
Cardiovascular · 105d
Cleared Feb 02, 2009
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER
K083313
Avinger, Inc.
Cardiovascular · 84d
Cleared Jan 27, 2009
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
K081878
LeMaitre Vascular, Inc.
Cardiovascular · 209d
Cleared Jan 15, 2009
MINNIE SUPPORT CATHETER
K082337
Vascular Solutions, Inc.
Cardiovascular · 154d
Cleared Dec 24, 2008
CONQUEST PTA BALLOON DILATATION CATHETER
K083657
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Dec 12, 2008
CPS AIM SL SLITTABLE INNER CATHETER
K082932
St Jude Medical
Cardiovascular · 72d
Cleared Dec 11, 2008
CHAPERON GUIDING CATHETER
K082385
MicroVention, Inc.
Cardiovascular · 114d
Cleared Dec 11, 2008
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K082559
Spectranetics Corp.
Cardiovascular · 98d
Cleared Dec 10, 2008
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
K082561
Spectranetics Corp.
Cardiovascular · 97d
Cleared Dec 09, 2008
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
K080428
Medtronic, Inc.
Cardiovascular · 294d
Cleared Dec 04, 2008
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
K082670
Medtronic, Inc.
Cardiovascular · 80d