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
Cleared
Oct 10, 1978
PRESSURE MONITORING INJECTION LINES
Cobe Laboratories, Inc.
Cardiovascular
29d
Cleared
May 09, 1978
MYOCATH KIT
Sorensen Research
Cardiovascular
36d
Cleared
Jun 27, 1977
CATHETER, POLYURETHANE, W/STYLET
Abbott Laboratories
Cardiovascular
46d
Cleared
Mar 14, 1977
PUNCTURE KIT, INTERNAL JUGULAR
Arrow Intl., Inc.
Cardiovascular
5d