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
May 09, 1983
ANGIOGRAPHIC NEEDLE
Medrad, Inc.
Cardiovascular
27d
Cleared
Apr 30, 1983
CENTRAL VEIN CATHERIZATION KIT-14-690-
Norton Performance Plastics Corp.
Cardiovascular
47d
Cleared
Apr 28, 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
Mallinckrodt Critical Care
Cardiovascular
79d
Cleared
Apr 12, 1983
FORGARTY BALLOON CALIBRATOR
American Edwards Laboratories
Cardiovascular
35d
Cleared
Mar 24, 1983
VERTEX DIGITAL SUBSTRATION KIT
Professional Medical Services
Cardiovascular
23d
Cleared
Mar 17, 1983
LYMPHANGIOGRAPHY SET
Vertex Medical Corp.
Cardiovascular
22d
Cleared
Mar 16, 1983
CATHETER CONNECTION W/INTEGRAL INJECTATE
Gould, Inc.
Cardiovascular
27d
Cleared
Mar 11, 1983
VARIOUS CARDIOVASCULAR PRODUCTS
C.R. Bard, Inc.
Cardiovascular
126d
Cleared
Feb 28, 1983
POLYETHYLENE MONITORING CONNECTORS
Vertex Medical Corp.
Cardiovascular
20d
Cleared
Feb 18, 1983
TRANSLUCENT POLY. CATH. CONNECTOR AND
Vertex Medical Corp.
Cardiovascular
24d
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
POLYETHYLENE CARDIOVASCULAR CATHETER
Vertex Medical Corp.
Cardiovascular
32d
Cleared
Sep 28, 1982
TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS
Vertex Medical Corp.
Cardiovascular
32d
Cleared
Sep 28, 1982
CORONARY INFUSION KIT
Mallinckrodt Critical Care
Cardiovascular
27d
Cleared
Sep 21, 1982
VERTEX PERCUTANEOUS PUNCTURE NEEDLE
Vertex Medical Corp.
Cardiovascular
25d
Cleared
Aug 31, 1982
STERILE PROTECTIVE SLEEVE W/TOUGH-BORST
Universal Medical Instrument Corp.
Cardiovascular
29d
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
Nov 27, 1981
VYGON EXTENSION TUBES & CONNECTORS
Exco, Inc.
Cardiovascular
22d
Cleared
Nov 27, 1981
LEADER-CATH
Exco, Inc.
Cardiovascular
22d