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
Jun 27, 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
Cordis Corp.
Cardiovascular
31d
Cleared
Feb 26, 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
Cordis Corp.
Cardiovascular
105d
Cleared
Jan 02, 1985
PTCA GUIDING CATHER
Cordis Corp.
Cardiovascular
71d
Cleared
Mar 11, 1983
VARIOUS CARDIOVASCULAR PRODUCTS
C.R. Bard, Inc.
Cardiovascular
126d
Cleared
Mar 05, 1981
USCI CARDIOVASCULAR CATHETER
C.R. Bard, Inc.
Cardiovascular
15d
Cleared
Oct 31, 1980
STERI-SLEEVE
Cordis Corp.
Cardiovascular
8d
Cleared
Dec 20, 1978
CATHETER, DIGITAL POSITRAL II
C.R. Bard, Inc.
Cardiovascular
6d
Cleared
Jun 27, 1977
CATHETER, POLYURETHANE, W/STYLET
Abbott Laboratories
Cardiovascular
46d