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 Scimed Life Systems, Inc..

501
Total
501
Cleared
122d
Avg days
1976
Since
501 devices
217–240 of 501
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 Nov 06, 1989
ARROW HANDS-OFF THERMO-PACE
K895268
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Aug 03, 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580
Boston Scientific Corp
Cardiovascular · 136d
Cleared May 19, 1989
E-Z-FLOW ANGIOGRAPHY CATHETERS
K890206
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared Apr 24, 1989
USCI 7F GUIDE CATHETER
K890420
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Apr 21, 1989
IMAGER FLUSH CATHETERS
K884354
Medi-Tech, Inc.
Cardiovascular · 186d
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 Jul 28, 1988
SLIP-COAT(TM) CATHETERS
K882796
Cook, Inc.
Cardiovascular · 22d
Cleared Feb 05, 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815
Target Therapeutics
Cardiovascular · 77d
Cleared Nov 27, 1987
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Sep 15, 1987
GUIDING CATHETER
K873004
Mallinckrodt Critical Care
Cardiovascular · 42d
Cleared Aug 12, 1987
DOUBLE LUMEN CATHETER
K872248
Cordis Corp.
Cardiovascular · 61d
Cleared Feb 20, 1987
NUMED BALLOON WEDGE PRESSURE CATHETER
K864943
NuMED, Inc.
Cardiovascular · 65d
Cleared Feb 19, 1987
NUMED BALLOON ANGIOGRAPHIC CATHETERS
K864940
NuMED, Inc.
Cardiovascular · 64d
Cleared Nov 03, 1986
CORDIS CONTRAST INJECTION LINES
K864141
Cordis Corp.
Cardiovascular · 12d
Cleared Oct 10, 1986
TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER
K863137
Terumo Medical Corp.
Cardiovascular · 56d
Cleared Sep 11, 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673
Medtronic Vascular
Cardiovascular · 59d
Cleared Aug 29, 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466
Shiley, Inc.
Cardiovascular · 60d