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
Jan 28, 2009
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
Vascular Solutions, Inc.
Cardiovascular
212d
Cleared
Sep 24, 2008
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
Terumo Medical Corp.
Cardiovascular
6d
Cleared
Apr 17, 2008
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
Vascular Solutions, Inc.
Cardiovascular
119d
Cleared
Feb 01, 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
Vascular Solutions, Inc.
Cardiovascular
80d
Cleared
Dec 18, 2007
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
Concentric Medical, Inc.
Cardiovascular
78d
Cleared
Oct 05, 2007
MICRUS COURIER ENZO MICROCATHETER 0.0190
Micrus Endovascular Corporation
Cardiovascular
28d
Cleared
May 24, 2007
MICRUS COURIER ENZO MICROCATHETER 0.017
Micrus Endovascular Corporation
Cardiovascular
97d
Cleared
Apr 16, 2007
DYE MANAGEMENT SYSTEM
Icu Medical, Inc.
Cardiovascular
116d
Cleared
Jan 18, 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
Vascular Solutions, Inc.
Cardiovascular
114d
Cleared
Jan 05, 2007
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
Vascular Solutions, Inc.
Cardiovascular
122d
Cleared
Nov 30, 2006
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
Boston Scientific Corp
Radiology
28d
Cleared
Aug 24, 2006
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
AngioDynamics, Inc.
Cardiovascular
65d
Cleared
Aug 04, 2006
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00
Micrus Endovascular Corporation
Cardiovascular
23d
Cleared
Aug 02, 2006
LANGSTON DUAL LUMEN CATHETER
Vascular Solutions, Inc.
Cardiovascular
58d
Cleared
Jun 23, 2006
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
Infraredx, Inc.
Cardiovascular
252d
Cleared
May 12, 2006
MICRUS COURIER MICROCATHETERS
Micrus Endovascular Corporation
Cardiovascular
115d
Cleared
Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
Boston Scientific Corp
Cardiovascular
60d
Cleared
Mar 08, 2006
THEROX INFUSION CATHETER, MODEL INCA-1
Therox, Inc.
Cardiovascular
163d
Cleared
Jan 19, 2006
MERIT IMPRESS DIAGNOSTIC CATHETER
Merit Medical Systems, Inc.
Cardiovascular
66d
Cleared
Dec 22, 2005
HOSPIRA CATH LAB CONVENIENCE KITS
Icu Medical, Inc.
Cardiovascular
72d
Cleared
Nov 02, 2005
ASAHI ANGIOGRAPHIC CATHETER
Asahi Intecc Co., Ltd.
Cardiovascular
142d
Cleared
Sep 02, 2005
IMAGER II ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
150d
Cleared
Jun 24, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
Vascular Solutions, Inc.
Cardiovascular
28d
Cleared
Jun 07, 2005
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
Medrad, Inc.
Cardiovascular
113d