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..
500
Total
500
Cleared
122d
Avg days
1976
Since
500 devices
Cleared
Oct 23, 1991
CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER
Cordis Corp.
Cardiovascular
37d
Cleared
Oct 18, 1991
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
Cordis Corp.
Cardiovascular
39d
Cleared
Jun 28, 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
Cordis Corp.
Cardiovascular
73d
Cleared
Jun 10, 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
Baxter Healthcare Corp
Cardiovascular
74d
Cleared
Apr 24, 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
Baxter Healthcare Corp
Cardiovascular
98d
Cleared
Apr 01, 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
Baxter Healthcare Corp
Cardiovascular
75d
Cleared
Feb 01, 1991
DIAVENTIONAL CATHETER
Cordis Corp.
Cardiovascular
66d
Cleared
Feb 01, 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
C.R. Bard, Inc.
Cardiovascular
39d
Cleared
Dec 17, 1990
MEWISSEN CATHETER
Boston Scientific Corp
Cardiovascular
55d
Cleared
Apr 23, 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
C.R. Bard, Inc.
Cardiovascular
256d
Cleared
Apr 06, 1990
SONICATH(TM) 5 F
Boston Scientific Corp
Cardiovascular
205d
Cleared
Mar 28, 1990
CORDIS SHUTTLE CATHETER
Cordis Corp.
Cardiovascular
147d
Cleared
Dec 28, 1989
MULTILUMEN CENTRAL VENOUS CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular
373d
Cleared
Nov 27, 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
Baxter Healthcare Corp
Cardiovascular
165d
Cleared
Aug 03, 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
Boston Scientific Corp
Cardiovascular
136d
Cleared
Apr 24, 1989
USCI 7F GUIDE CATHETER
C.R. Bard, Inc.
Cardiovascular
88d
Cleared
Jan 18, 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
C.R. Bard, Inc.
Cardiovascular
84d
Cleared
Jan 12, 1989
CATH LAB MONITORING CATHETER
C.R. Bard, Inc.
Cardiovascular
108d
Cleared
Oct 06, 1988
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
C.R. Bard, Inc.
Cardiovascular
79d
Cleared
Nov 27, 1987
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
C.R. Bard, Inc.
Cardiovascular
92d
Cleared
Aug 12, 1987
DOUBLE LUMEN CATHETER
Cordis Corp.
Cardiovascular
61d
Cleared
Nov 03, 1986
CORDIS CONTRAST INJECTION LINES
Cordis Corp.
Cardiovascular
12d
Cleared
Sep 11, 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
Medtronic Vascular
Cardiovascular
59d
Cleared
Aug 25, 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
Cordis Corp.
Cardiovascular
74d