DQO · Class II · 21 CFR 870.1200

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
361–384 of 501
Cleared May 09, 1983
ANGIOGRAPHIC NEEDLE
K831189
Medrad, Inc.
Cardiovascular · 27d
Cleared Apr 30, 1983
CENTRAL VEIN CATHERIZATION KIT-14-690-
K830788
Norton Performance Plastics Corp.
Cardiovascular · 47d
Cleared Apr 28, 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415
Mallinckrodt Critical Care
Cardiovascular · 79d
Cleared Apr 12, 1983
FORGARTY BALLOON CALIBRATOR
K830734
American Edwards Laboratories
Cardiovascular · 35d
Cleared Mar 24, 1983
VERTEX DIGITAL SUBSTRATION KIT
K830637
Professional Medical Services
Cardiovascular · 23d
Cleared Mar 17, 1983
LYMPHANGIOGRAPHY SET
K830576
Vertex Medical Corp.
Cardiovascular · 22d
Cleared Mar 16, 1983
CATHETER CONNECTION W/INTEGRAL INJECTATE
K830523
Gould, Inc.
Cardiovascular · 27d
Cleared Mar 11, 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357
C.R. Bard, Inc.
Cardiovascular · 126d
Cleared Feb 28, 1983
POLYETHYLENE MONITORING CONNECTORS
K830420
Vertex Medical Corp.
Cardiovascular · 20d
Cleared Feb 18, 1983
TRANSLUCENT POLY. CATH. CONNECTOR AND
K830237
Vertex Medical Corp.
Cardiovascular · 24d
Cleared Jan 27, 1983
INTRACATH-DA INTRAVENOUS CATH. PLACEMENT
K823064
Parke-Davis Co.
Cardiovascular · 101d
Cleared Jan 21, 1983
SIDEARM Y-ADAPTOR
K823243
American Edwards Laboratories
Cardiovascular · 81d
Cleared Dec 15, 1982
INTRA CATH-DSA INTRAVENOUS CATH PLACE.
K823065
Parke-Davis Co.
Cardiovascular · 58d
Cleared Oct 18, 1982
BRACHIAL CORONARY GUIDING CATHETER
K822862
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared Sep 28, 1982
POLYETHYLENE CARDIOVASCULAR CATHETER
K822594
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS
K822598
Vertex Medical Corp.
Cardiovascular · 32d
Cleared Sep 28, 1982
CORONARY INFUSION KIT
K822640
Mallinckrodt Critical Care
Cardiovascular · 27d
Cleared Sep 21, 1982
VERTEX PERCUTANEOUS PUNCTURE NEEDLE
K822596
Vertex Medical Corp.
Cardiovascular · 25d
Cleared Aug 31, 1982
STERILE PROTECTIVE SLEEVE W/TOUGH-BORST
K822290
Universal Medical Instrument Corp.
Cardiovascular · 29d
Cleared Aug 24, 1982
ANGIOGRAPHIC CATHETER
K821816
Medi-Tech, Inc.
Cardiovascular · 64d
Cleared Jul 20, 1982
ANGIOGRAPHY KIT
K821976
Mallinckrodt Critical Care
Cardiovascular · 14d
Cleared Jan 29, 1982
CORONARY INFUSION KIT
K820001
Mallinckrodt Critical Care
Cardiovascular · 25d
Cleared Nov 27, 1981
VYGON EXTENSION TUBES & CONNECTORS
K813140
Exco, Inc.
Cardiovascular · 22d
Cleared Nov 27, 1981
LEADER-CATH
K813142
Exco, Inc.
Cardiovascular · 22d