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
577–600 of 895
Cleared Mar 29, 2000
ZUMA GUIDE CATHETERS
K000677
Medtronic Vascular
Cardiovascular · 29d
Cleared Mar 24, 2000
5F GUIDING CATHETER
K000598
Guidant Corp.
Cardiovascular · 30d
Cleared Feb 25, 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Nov 16, 1999
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017
K991059
Spectranetics Corp.
Cardiovascular · 231d
Cleared Oct 28, 1999
DUAL LUMEN CATHETER, MODEL DL-35-90
K991601
Endologix, Inc.
Cardiovascular · 171d
Cleared Oct 12, 1999
VISTA BRITE TIP CATHETERS
K992673
Cordis Corp.
Cardiovascular · 63d
Cleared Sep 29, 1999
INTRAMAX ITI GUIDE CATHETER
K992622
Intratherapeutics, Inc.
Cardiovascular · 55d
Cleared Jul 30, 1999
AVE GL-1 GUIDING CATHETER
K984482
Arterial Vascular Engineering Massachusetts, Inc.
Cardiovascular · 226d
Cleared Jun 22, 1999
NAVIPORT DEFLECTABLE TIP GUIDING CATHETER
K974683
Cardima, Inc.
Cardiovascular · 553d
Cleared Apr 07, 1999
ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
K981191
Intratherapeutics, Inc.
Cardiovascular · 370d
Cleared Apr 02, 1999
ENVY GUIDING CATHETER
K990726
Cook, Inc.
Cardiovascular · 28d
Cleared Mar 22, 1999
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
K990707
Medtronics Interventional Vascular
Cardiovascular · 18d
Cleared Jan 27, 1999
AURORA
K972065
Neurovena Corp.
Cardiovascular · 603d
Cleared Jan 27, 1999
GT LEGGIERO
K981359
Terumo Medical Corp.
Cardiovascular · 288d
Cleared Nov 20, 1998
URESIL VASCU-FLO INFUSION CATHETER
K980278
Uresil Corp.
Cardiovascular · 298d
Cleared Sep 04, 1998
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
K982883
Medtronics Interventional Vascular
Cardiovascular · 18d
Cleared Aug 18, 1998
ENVOY AND VISTA BRITE TIP
K982632
Cordis Corp.
Cardiovascular · 26d
Cleared Aug 18, 1998
6F ENVOY GUIDING CATHETER
K982770
Cordis Corp.
Cardiovascular · 26d
Cleared Aug 11, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K980453
Boston Scientific Scimed, Inc.
Cardiovascular · 187d
Cleared Aug 07, 1998
MEDTRONIC ZUMA GUIDING CATHETER
K981198
Medtronics Interventional Vascular
Cardiovascular · 127d
Cleared Jun 26, 1998
CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER
K973298
Cardima, Inc.
Cardiovascular · 297d
Cleared Jun 10, 1998
THE AMPLANTZ GOOSE NECK MICROSNARE
K970668
Microvena Corp.
Cardiovascular · 471d
Cleared May 13, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K981413
Boston Scientific Scimed, Inc.
Cardiovascular · 23d
Cleared Feb 19, 1998
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
K974684
Scimed Life Systems, Inc.
Cardiovascular · 65d