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
Jul 16, 2012
HEARTRAIL III GUIDING CATHETER
Terumo Corporation
Cardiovascular
245d
Cleared
Jul 11, 2012
MONGOOSE ANGIOGRAPHIC CATHETER
Pediacath, Inc.
Cardiovascular
197d
Cleared
Jun 14, 2012
SUREFIRE HI-FLOW MICROCATHETER
Surefire Medical, Inc.
Cardiovascular
7d
Cleared
May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
94d
Cleared
Mar 30, 2012
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
AngioDynamics, Inc.
Cardiovascular
218d
Cleared
Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
Boston Scientific Corp
Cardiovascular
6d
Cleared
Mar 09, 2012
MODIFIED CONCENTIRC MICROCATHETER
Concentric Medical, Inc.
Cardiovascular
126d
Cleared
Feb 23, 2012
SUREFIRE GUIDE SHEATH
Surefire Medical, Inc.
Cardiovascular
65d
Cleared
Jan 05, 2012
NMI 2.8 MICROCATHETER
Navilyst Medical, Inc.
Cardiovascular
27d
Cleared
Aug 19, 2011
MICROCATHETER
Navilyst Medical, Inc.
Cardiovascular
25d
Cleared
Jul 06, 2011
MODIFIED CONCENTRIC MICROCATHETER
Concentric Medical, Inc.
Cardiovascular
26d
Cleared
Jul 01, 2011
MERIT MARQUIS FLOW SWITCH
Merit Medical Systems, Inc.
Cardiovascular
119d
Cleared
Jun 24, 2011
SUREFIRE INFUSION CATHETER SYSTEM
Surefire Medical, Inc.
Cardiovascular
127d
Cleared
Feb 11, 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
Edwards Lifesciences, LLC
Cardiovascular
29d
Cleared
Jul 19, 2010
COHEN CROSSOVER CATHETER
Vascular Solutions, Inc.
Cardiovascular
40d
Cleared
Jun 02, 2010
VIEWFLEX PLUS ICE CATHETER
St Jude Medical
Cardiovascular
30d
Cleared
Feb 12, 2010
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
Merit Medical Systems, Inc.
Cardiovascular
137d
Cleared
Jan 13, 2010
ANGIOGRAPHIC CATHETER, MODEL ANGIOS
Oscor, Inc.
Cardiovascular
183d
Cleared
Nov 20, 2009
MICRUS MICROCATHETER, MODEL COURIER 270
Micrus Endovascular Corporation
Cardiovascular
79d
Cleared
Sep 11, 2009
HEARTRAIL III GUIDING CATHETER
Terumo Corp.
Cardiovascular
37d
Cleared
Jul 30, 2009
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
Concentric Medical, Inc.
Cardiovascular
29d
Cleared
May 06, 2009
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
Micrus Endovascular Corporation
Cardiovascular
126d
Cleared
Feb 19, 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
15d
Cleared
Feb 06, 2009
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
Terumo Medical Corp.
Cardiovascular
31d