DQO · Class II · 21 CFR 870.1200

FDA Product Code DQO: Catheter, Intravascular, Diagnostic

FDA product code DQO covers diagnostic intravascular catheters used for hemodynamic assessment and angiography.

These catheters are advanced into heart chambers or vessels to measure intracardiac and intravascular pressures, sample blood for oxygen saturation, and inject contrast for angiographic imaging. They are used in cardiac catheterization laboratory diagnostic studies.

DQO devices are Class II medical devices, regulated under 21 CFR 870.1200 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Cordis Corp., Boston Scientific Corp and C.R. Bard, Inc..

501
Total
501
Cleared
122d
Avg days
1976
Since
501 devices
49–72 of 501
Cleared Aug 19, 2016
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
K161287
Medtronic Vascular
Cardiovascular · 102d
Cleared Mar 11, 2016
Surefire Infusion System
K160662
Surefire Medical, Inc.
Cardiovascular · 2d
Cleared Jan 13, 2016
IntraNovo Microcatheter
K153125
Texasmedical Technologies, Inc.
Cardiovascular · 76d
Cleared Dec 18, 2015
Foresight Intracardiac Echocardiography (ICE) System
K151126
Colibri Technologies, Inc.
Cardiovascular · 234d
Cleared Oct 29, 2015
Impulse Angiographic Catheter, Expo Angiographic Catheter
K152605
Boston Scientific Corporation
Cardiovascular · 48d
Cleared Oct 19, 2015
Radifocus Optitorque Angiographic Catheter
K150232
Ashitaka Factory of Terumo Corp.
Cardiovascular · 259d
Cleared Oct 14, 2015
AngioDynamics Mariner Angiographic Catheters
K151724
AngioDynamics, Inc.
Cardiovascular · 110d
Cleared Jun 26, 2015
Plato MICROCATH 27B Microcatheter
K143398
Scientia Vascular, LLC
Cardiovascular · 212d
Cleared Jun 25, 2015
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
K143604
Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
Cardiovascular · 189d
Cleared Apr 23, 2015
IntraNovo 25 Microcatheter
K142817
Texasmedical Technologies, Inc.
Cardiovascular · 206d
Cleared Mar 20, 2015
SUMMED HIGH PRESSURE LINE
K140356
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular · 401d
Cleared Jan 12, 2015
Surefire Infusion System 021
K143588
Surefire Medical, Inc.
Cardiovascular · 25d
Cleared Jan 09, 2015
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130
Cook, Inc.
Cardiovascular · 466d
Cleared Sep 19, 2014
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
K141453
Lightlab Imaging, Inc.
Cardiovascular · 109d
Cleared Aug 18, 2014
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
K141769
Lightlab Imaging, Inc.
Cardiovascular · 48d
Cleared Feb 26, 2014
PRESSURE CONNECTING TUBE
K131770
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Cardiovascular · 254d
Cleared Oct 11, 2013
MODIFIED CONCENTRIC MICROCATHETER
K131437
Concentric Medical, Inc.
Cardiovascular · 144d
Cleared Mar 04, 2013
URSA ANGIOGRAPHIC CATHETER
K123818
Curative Medical Technology, Inc.
Cardiovascular · 82d
Cleared Dec 14, 2012
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
K122937
Cook, Inc.
Cardiovascular · 81d
Cleared Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
K121694
Boston Scientific Corp
Cardiovascular · 99d
Cleared Aug 17, 2012
MEDLINE HIGH PRESSURE INJECTION TUBING
K120008
Medline Industries, Inc.
Cardiovascular · 227d
Cleared Aug 02, 2012
HEADWAY DUO MICROCATHETER
K120917
MicroVention, Inc.
Cardiovascular · 128d
Cleared Jul 30, 2012
PLATO MICROCATH 27 MICROCATHETER
K121734
Scientia Vascular, LLC
Cardiovascular · 47d
Cleared Jul 17, 2012
NMI MICROCATHETER
K121954
Navilyst Medical, Inc.
Cardiovascular · 14d