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..

500
Total
500
Cleared
122d
Avg days
1976
Since
500 devices
97–120 of 500
Cleared Oct 23, 1991
CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER
K914141
Cordis Corp.
Cardiovascular · 37d
Cleared Oct 18, 1991
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
K914007
Cordis Corp.
Cardiovascular · 39d
Cleared Jun 28, 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
K911703
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 10, 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367
Baxter Healthcare Corp
Cardiovascular · 74d
Cleared Apr 24, 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204
Baxter Healthcare Corp
Cardiovascular · 98d
Cleared Apr 01, 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208
Baxter Healthcare Corp
Cardiovascular · 75d
Cleared Feb 01, 1991
DIAVENTIONAL CATHETER
K905297
Cordis Corp.
Cardiovascular · 66d
Cleared Feb 01, 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727
C.R. Bard, Inc.
Cardiovascular · 39d
Cleared Dec 17, 1990
MEWISSEN CATHETER
K904788
Boston Scientific Corp
Cardiovascular · 55d
Cleared Apr 23, 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180
C.R. Bard, Inc.
Cardiovascular · 256d
Cleared Apr 06, 1990
SONICATH(TM) 5 F
K895542
Boston Scientific Corp
Cardiovascular · 205d
Cleared Mar 28, 1990
CORDIS SHUTTLE CATHETER
K896308
Cordis Corp.
Cardiovascular · 147d
Cleared Dec 28, 1989
MULTILUMEN CENTRAL VENOUS CATHETER
K885221
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 373d
Cleared Nov 27, 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168
Baxter Healthcare Corp
Cardiovascular · 165d
Cleared Aug 03, 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580
Boston Scientific Corp
Cardiovascular · 136d
Cleared Apr 24, 1989
USCI 7F GUIDE CATHETER
K890420
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Jan 18, 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502
C.R. Bard, Inc.
Cardiovascular · 84d
Cleared Jan 12, 1989
CATH LAB MONITORING CATHETER
K884065
C.R. Bard, Inc.
Cardiovascular · 108d
Cleared Oct 06, 1988
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051
C.R. Bard, Inc.
Cardiovascular · 79d
Cleared Nov 27, 1987
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Aug 12, 1987
DOUBLE LUMEN CATHETER
K872248
Cordis Corp.
Cardiovascular · 61d
Cleared Nov 03, 1986
CORDIS CONTRAST INJECTION LINES
K864141
Cordis Corp.
Cardiovascular · 12d
Cleared Sep 11, 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673
Medtronic Vascular
Cardiovascular · 59d
Cleared Aug 25, 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
K862244
Cordis Corp.
Cardiovascular · 74d