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
Apr 12, 1983
FORGARTY BALLOON CALIBRATOR
American Edwards Laboratories
Cardiovascular
35d
Cleared
Mar 11, 1983
VARIOUS CARDIOVASCULAR PRODUCTS
C.R. Bard, Inc.
Cardiovascular
126d
Cleared
Jan 27, 1983
INTRACATH-DA INTRAVENOUS CATH. PLACEMENT
Parke-Davis Co.
Cardiovascular
101d
Cleared
Jan 21, 1983
SIDEARM Y-ADAPTOR
American Edwards Laboratories
Cardiovascular
81d
Cleared
Dec 15, 1982
INTRA CATH-DSA INTRAVENOUS CATH PLACE.
Parke-Davis Co.
Cardiovascular
58d
Cleared
Oct 18, 1982
BRACHIAL CORONARY GUIDING CATHETER
Advanced Cardiovascular Systems, Inc.
Cardiovascular
21d
Cleared
Sep 28, 1982
CORONARY INFUSION KIT
Mallinckrodt Critical Care
Cardiovascular
27d
Cleared
Aug 24, 1982
ANGIOGRAPHIC CATHETER
Medi-Tech, Inc.
Cardiovascular
64d
Cleared
Jul 20, 1982
ANGIOGRAPHY KIT
Mallinckrodt Critical Care
Cardiovascular
14d
Cleared
Jan 29, 1982
CORONARY INFUSION KIT
Mallinckrodt Critical Care
Cardiovascular
25d
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
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