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 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 17, 2012
NMI MICROCATHETER
K121954
Navilyst Medical, Inc.
Cardiovascular · 14d
Cleared May 21, 2012
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
K120495
Boston Scientific Corp
Cardiovascular · 94d
Cleared Mar 30, 2012
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
K112452
AngioDynamics, Inc.
Cardiovascular · 218d
Cleared Mar 29, 2012
IMAGER II ANGIOGRAPHIC CATHETERS
K120893
Boston Scientific Corp
Cardiovascular · 6d
Cleared Mar 09, 2012
MODIFIED CONCENTIRC MICROCATHETER
K113260
Concentric Medical, Inc.
Cardiovascular · 126d
Cleared Jan 05, 2012
NMI 2.8 MICROCATHETER
K113638
Navilyst Medical, Inc.
Cardiovascular · 27d
Cleared Aug 19, 2011
MICROCATHETER
K112124
Navilyst Medical, Inc.
Cardiovascular · 25d
Cleared Jul 06, 2011
MODIFIED CONCENTRIC MICROCATHETER
K111619
Concentric Medical, Inc.
Cardiovascular · 26d
Cleared Jul 01, 2011
MERIT MARQUIS FLOW SWITCH
K110643
Merit Medical Systems, Inc.
Cardiovascular · 119d
Cleared Feb 11, 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
K110103
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Jul 19, 2010
COHEN CROSSOVER CATHETER
K101625
Vascular Solutions, Inc.
Cardiovascular · 40d
Cleared Jun 02, 2010
VIEWFLEX PLUS ICE CATHETER
K101239
St Jude Medical
Cardiovascular · 30d
Cleared Feb 12, 2010
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
K093004
Merit Medical Systems, Inc.
Cardiovascular · 137d
Cleared Jan 13, 2010
ANGIOGRAPHIC CATHETER, MODEL ANGIOS
K092118
Oscor, Inc.
Cardiovascular · 183d
Cleared Jul 30, 2009
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
K091961
Concentric Medical, Inc.
Cardiovascular · 29d
Cleared Feb 19, 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Feb 06, 2009
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
K090040
Terumo Medical Corp.
Cardiovascular · 31d
Cleared Jan 28, 2009
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
K081846
Vascular Solutions, Inc.
Cardiovascular · 212d
Cleared Sep 24, 2008
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736
Terumo Medical Corp.
Cardiovascular · 6d
Cleared Apr 17, 2008
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
K073585
Vascular Solutions, Inc.
Cardiovascular · 119d