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 Vascular Solutions, Inc..

893
Total
893
Cleared
104d
Avg days
1979
Since
893 devices
217–240 of 893
Cleared Apr 24, 2013
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM
K122826
Volcano Corporation
Cardiovascular · 222d
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 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 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 Jun 13, 2012
CONCIERGE GUIDING CATHETER
K121051
Merit Medical Systems, Inc.
Cardiovascular · 68d
Cleared May 15, 2012
SWITCH-IT CATHETER
K120707
Vascular Solutions, Inc.
Cardiovascular · 68d
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 Feb 24, 2012
ENVOY DISTAL ACCESS GUIDING CATHETER
K120229
Codman & Shurtleff, Inc.
Cardiovascular · 30d
Cleared Jan 05, 2012
VALET MICRO CATHETER
K112035
Volcano Corporation
Cardiovascular · 174d
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 Oct 27, 2011
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
K112917
Medtronic, Inc.
Cardiovascular · 24d
Cleared Oct 25, 2011
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
K112828
Codman & Shurtleff, Inc.
Cardiovascular · 27d
Cleared Sep 26, 2011
SELECTRA ACCESSORY KIT
K111839
Biotronik, Inc.
Cardiovascular · 89d