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
Nov 16, 1981
PET POLYETHYLENE TORQUE CATHETER
Universal Medical Instrument Corp.
Cardiovascular
21d
Cleared
Mar 27, 1981
GANZ CORONARY REPERFUSION CATHETER
American Edwards Laboratories
Cardiovascular
88d
Cleared
Mar 11, 1981
BAIM TM CORONARY SINUS FLOW THERMAL
Electro-Catheter Corp.
Cardiovascular
29d
Cleared
Mar 05, 1981
USCI CARDIOVASCULAR CATHETER
C.R. Bard, Inc.
Cardiovascular
15d
Cleared
Dec 19, 1980
PRESSURE MONITORING SET
Norton Performance Plastics Corp.
Cardiovascular
30d
Cleared
Oct 31, 1980
STERI-SLEEVE
Cordis Corp.
Cardiovascular
8d
Cleared
Jun 30, 1980
PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE
Graphic Controls Corp.
Cardiovascular
25d
Cleared
Jun 30, 1980
MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS
Graphic Controls Corp.
Cardiovascular
25d
Cleared
Apr 29, 1980
EXTENSION LINE
Norton Performance Plastics Corp.
Cardiovascular
42d
Cleared
Apr 24, 1980
SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET
Norton Performance Plastics Corp.
Cardiovascular
37d
Cleared
Apr 16, 1980
CENTRAL VEIN CATHETERIZATION KIT
Medical Components, Inc.
Cardiovascular
13d
Cleared
Mar 12, 1980
CENTRAL VENOUS PRESSURE CATHETER
Medical Components, Inc.
Cardiovascular
12d
Cleared
Dec 19, 1979
WHITE SEALING CAP
Quinton, Inc.
Cardiovascular
85d
Cleared
Feb 01, 1979
CATHETER TUBING MODIFICATION
Jelco Laboratories
Cardiovascular
16d
Cleared
Jan 15, 1979
POST EXTRA SYSTOLIC POTENTIATOR
Medrad, Inc.
Cardiovascular
80d
Cleared
Dec 20, 1978
CATHETER, DIGITAL POSITRAL II
C.R. Bard, Inc.
Cardiovascular
6d
Cleared
Oct 10, 1978
PRESSURE MONITORING INJECTION LINES
Cobe Laboratories, Inc.
Cardiovascular
29d
Cleared
May 09, 1978
MYOCATH KIT
Sorensen Research
Cardiovascular
36d
Cleared
Nov 17, 1977
PRESSURE TUBING
Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular
51d
Cleared
Jun 27, 1977
CATHETER, POLYURETHANE, W/STYLET
Abbott Laboratories
Cardiovascular
46d
Cleared
Mar 15, 1977
MONITORING KIT, CENTRAL VENOUS PRESSURE
Argon Medical Corp.
Cardiovascular
29d
Cleared
Mar 14, 1977
PUNCTURE KIT, INTERNAL JUGULAR
Arrow Intl., Inc.
Cardiovascular
5d