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
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 17, 2012
NMI MICROCATHETER
Navilyst Medical, Inc.
Cardiovascular
14d
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
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
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
Jul 30, 2009
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
Concentric Medical, Inc.
Cardiovascular
29d
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
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