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 Sep 09, 2011
BIOTEQ ANGIOGRAPHIC CATHETER
K102633
Bioteque Corp.
Cardiovascular · 361d
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 Jul 01, 2010
THERMODILUTION CATHETER
K101669
Biosensors Intl. Pte. , Ltd.
Cardiovascular · 17d
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 29, 2010
URSA ANGIOGRAPHIC CATHETER
K090427
Curative Medical Technology, Inc.
Cardiovascular · 344d
Cleared Jan 13, 2010
ANGIOGRAPHIC CATHETER, MODEL ANGIOS
K092118
Oscor, Inc.
Cardiovascular · 183d
Cleared Jan 05, 2010
THERMODILUTION CATHETER
K083384
Biosensors Intl. Pte. , Ltd.
Cardiovascular · 414d
Cleared Nov 20, 2009
MICRUS MICROCATHETER, MODEL COURIER 270
K092702
Micrus Endovascular Corporation
Cardiovascular · 79d
Cleared Oct 16, 2009
GUIDED MEASUREMENT CATHETER (GMC)
K091780
Mediguide, Ltd.
Cardiovascular · 121d