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
73–96 of 501
Cleared Jul 16, 2012
HEARTRAIL III GUIDING CATHETER
K113335
Terumo Corporation
Cardiovascular · 245d
Cleared Jul 11, 2012
MONGOOSE ANGIOGRAPHIC CATHETER
K113819
Pediacath, Inc.
Cardiovascular · 197d
Cleared Jun 14, 2012
SUREFIRE HI-FLOW MICROCATHETER
K121677
Surefire Medical, Inc.
Cardiovascular · 7d
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 Feb 23, 2012
SUREFIRE GUIDE SHEATH
K113737
Surefire Medical, Inc.
Cardiovascular · 65d
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 Jun 24, 2011
SUREFIRE INFUSION CATHETER SYSTEM
K110459
Surefire Medical, Inc.
Cardiovascular · 127d
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 Nov 20, 2009
MICRUS MICROCATHETER, MODEL COURIER 270
K092702
Micrus Endovascular Corporation
Cardiovascular · 79d
Cleared Sep 11, 2009
HEARTRAIL III GUIDING CATHETER
K092372
Terumo Corp.
Cardiovascular · 37d
Cleared Jul 30, 2009
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
K091961
Concentric Medical, Inc.
Cardiovascular · 29d
Cleared May 06, 2009
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
K083922
Micrus Endovascular Corporation
Cardiovascular · 126d
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