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
289–312 of 895
Cleared Aug 12, 2013
CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER
K132197
Pendracare International, B.V.
Cardiovascular · 27d
Cleared Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493
C.R. Bard, Inc.
Cardiovascular · 71d
Cleared Jun 28, 2013
CODA BALLOON CATHETER
K122917
Cook, Inc.
Cardiovascular · 276d
Cleared Jun 25, 2013
PRIMI AND SECONDI SUPPORT CATHETERS
K130850
Thermopeutix, Inc.
Cardiovascular · 90d
Cleared May 29, 2013
ADROIT GUIDING CATHETER
K131225
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 29d
Cleared Apr 24, 2013
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM
K122826
Volcano Corporation
Cardiovascular · 222d
Cleared Apr 09, 2013
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
K123153
Medtronic, Ireland
Cardiovascular · 182d
Cleared Mar 20, 2013
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
K130252
St Jude Medical
Cardiovascular · 47d
Cleared Mar 20, 2013
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
K130257
St Jude Medical
Cardiovascular · 47d
Cleared Mar 19, 2013
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
K122940
Cook, Inc.
Cardiovascular · 176d
Cleared Mar 19, 2013
GUIDEZILLA GUIDE EXTENSION CATHETER
K123765
Boston Scientific
Cardiovascular · 102d
Cleared Jan 14, 2013
QXMEDICAL ACCESS & SUPPORT CATHETER
K123311
Qxmedical, LLC
Cardiovascular · 81d
Cleared Jan 11, 2013
SELECTRA 7F CATHETERS
K123324
Biotronik, Inc.
Cardiovascular · 77d
Cleared Jan 03, 2013
TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM
K123452
Stryker
Cardiovascular · 56d
Cleared Dec 21, 2012
NHANCER
K121077
Imds Operations B.V.
Cardiovascular · 256d
Cleared Dec 14, 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K123531
LeMaitre Vascular, Inc.
Cardiovascular · 28d
Cleared Dec 07, 2012
REVERSE MEDICAL MICROCATHETER
K122684
Reverse Medical Corporation
Cardiovascular · 98d
Cleared Nov 27, 2012
MULTICROSS SUPPORT CATHETER
K121763
Roxwood Medical, Inc.
Cardiovascular · 165d
Cleared Nov 21, 2012
MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
K122581
Concentric Medical, Inc.
Cardiovascular · 90d
Cleared Nov 20, 2012
PENUMBRA DDC CATHETERS
K122772
Penumbra, Inc.
Cardiovascular · 71d
Cleared Sep 25, 2012
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
K121219
Medtronic, Inc.
Cardiovascular · 155d
Cleared Aug 31, 2012
TYSHAK NUCLEUS
K121859
NuMED, Inc.
Cardiovascular · 66d
Cleared Aug 30, 2012
RUBICON 18 SUPPORT CATHETER
K122394
Boston Scientific Corp
Cardiovascular · 23d
Cleared Aug 23, 2012
AMPLATZER TORQVUE FX
K121611
Aga Medical Corporation
Cardiovascular · 83d