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, Cordis Corp. and C.R. Bard, Inc..

889
Total
889
Cleared
104d
Avg days
1979
Since
889 devices
169–192 of 889
Cleared Jan 12, 2018
Microcatheter
K173560
Surmodics,Inc.
Cardiovascular · 56d
Cleared Jan 04, 2018
Attain Assist CS Access Catheter
K171819
Creganna Medical Also Doing Business AS Ceganna Tactx Medica
Cardiovascular · 199d
Cleared Oct 20, 2017
GuideLiner V3 Catheter
K172090
Vascular Solutions, Inc.
Cardiovascular · 101d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452
Boston Scientific Corporation
Cardiovascular · 96d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 03, 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jun 07, 2017
Venture 038 catheter
K171335
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Mar 23, 2017
Guidezilla II Guide Extension Catheter
K163314
Boston Scientific Corporation
Cardiovascular · 120d
Cleared Feb 03, 2017
TrapLiner catheter
K161901
Vascular Solutions, Inc.
Cardiovascular · 207d
Cleared Feb 01, 2017
Twin-Pass Torque
K162467
Vascular Solutions, Inc.
Cardiovascular · 152d
Cleared Jan 05, 2017
YOGA Microcatheter
K162563
Codman & Shurtleff, Inc.
Cardiovascular · 113d
Cleared Dec 04, 2015
Stingray LP Catheter
K152401
Boston Scientific Corporation
Cardiovascular · 101d
Cleared Mar 26, 2014
TOTAL ACROSS
K133539
Medtronic Vascular
Cardiovascular · 128d
Cleared Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493
C.R. Bard, Inc.
Cardiovascular · 71d
Cleared Aug 30, 2012
RUBICON 18 SUPPORT CATHETER
K122394
Boston Scientific Corp
Cardiovascular · 23d
Cleared Jul 13, 2011
VACCESS PTA DILATATION CATHETER
K111850
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Jun 02, 2011
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
K111252
Boston Scientific Corp
Cardiovascular · 30d
Cleared Feb 06, 2009
6F TAIGA GUIDING CATHETER
K083422
Medtronic Vascular
Cardiovascular · 79d
Cleared Dec 24, 2008
CONQUEST PTA BALLOON DILATATION CATHETER
K083657
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Oct 25, 2006
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74
K061416
Medtronic Vascular
Cardiovascular · 156d
Cleared Oct 20, 2006
OCCLUSION BALLOON
K062202
Boston Scientific Corp
Cardiovascular · 80d
Cleared Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K062594
Boston Scientific Corporation
Cardiovascular · 19d
Cleared Sep 08, 2006
5F SHERPA ACTIVE NX GUIDE CATHETER
K062420
Medtronic Vascular
Cardiovascular · 21d