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
Cleared
Aug 19, 2016
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
Medtronic Vascular
Cardiovascular
102d
Cleared
Mar 11, 2016
Surefire Infusion System
Surefire Medical, Inc.
Cardiovascular
2d
Cleared
Jan 13, 2016
IntraNovo Microcatheter
Texasmedical Technologies, Inc.
Cardiovascular
76d
Cleared
Dec 18, 2015
Foresight Intracardiac Echocardiography (ICE) System
Colibri Technologies, Inc.
Cardiovascular
234d
Cleared
Oct 29, 2015
Impulse Angiographic Catheter, Expo Angiographic Catheter
Boston Scientific Corporation
Cardiovascular
48d
Cleared
Oct 19, 2015
Radifocus Optitorque Angiographic Catheter
Ashitaka Factory of Terumo Corp.
Cardiovascular
259d
Cleared
Oct 14, 2015
AngioDynamics Mariner Angiographic Catheters
AngioDynamics, Inc.
Cardiovascular
110d
Cleared
Jun 26, 2015
Plato MICROCATH 27B Microcatheter
Scientia Vascular, LLC
Cardiovascular
212d
Cleared
Jun 25, 2015
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
Cardiovascular
189d
Cleared
Apr 23, 2015
IntraNovo 25 Microcatheter
Texasmedical Technologies, Inc.
Cardiovascular
206d
Cleared
Mar 20, 2015
SUMMED HIGH PRESSURE LINE
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular
401d
Cleared
Jan 12, 2015
Surefire Infusion System 021
Surefire Medical, Inc.
Cardiovascular
25d
Cleared
Jan 09, 2015
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
Cook, Inc.
Cardiovascular
466d
Cleared
Sep 19, 2014
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
Lightlab Imaging, Inc.
Cardiovascular
109d
Cleared
Aug 18, 2014
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
Lightlab Imaging, Inc.
Cardiovascular
48d
Cleared
Feb 26, 2014
PRESSURE CONNECTING TUBE
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Cardiovascular
254d
Cleared
Oct 11, 2013
MODIFIED CONCENTRIC MICROCATHETER
Concentric Medical, Inc.
Cardiovascular
144d
Cleared
Mar 04, 2013
URSA ANGIOGRAPHIC CATHETER
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)
Cook, Inc.
Cardiovascular
81d
Cleared
Sep 14, 2012
IMAGER II ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
99d
Cleared
Aug 17, 2012
MEDLINE HIGH PRESSURE INJECTION TUBING
Medline Industries, Inc.
Cardiovascular
227d
Cleared
Aug 02, 2012
HEADWAY DUO MICROCATHETER
MicroVention, Inc.
Cardiovascular
128d
Cleared
Jul 30, 2012
PLATO MICROCATH 27 MICROCATHETER
Scientia Vascular, LLC
Cardiovascular
47d
Cleared
Jul 17, 2012
NMI MICROCATHETER
Navilyst Medical, Inc.
Cardiovascular
14d