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
265–288 of 501
Cleared Apr 12, 1983
FORGARTY BALLOON CALIBRATOR
K830734
American Edwards Laboratories
Cardiovascular · 35d
Cleared Mar 11, 1983
VARIOUS CARDIOVASCULAR PRODUCTS
K823357
C.R. Bard, Inc.
Cardiovascular · 126d
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
CORONARY INFUSION KIT
K822640
Mallinckrodt Critical Care
Cardiovascular · 27d
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 Mar 27, 1981
GANZ CORONARY REPERFUSION CATHETER
K803270
American Edwards Laboratories
Cardiovascular · 88d
Cleared Mar 11, 1981
BAIM TM CORONARY SINUS FLOW THERMAL
K810360
Electro-Catheter Corp.
Cardiovascular · 29d
Cleared Mar 05, 1981
USCI CARDIOVASCULAR CATHETER
K810412
C.R. Bard, Inc.
Cardiovascular · 15d
Cleared Dec 19, 1980
PRESSURE MONITORING SET
K802945
Norton Performance Plastics Corp.
Cardiovascular · 30d
Cleared Oct 31, 1980
STERI-SLEEVE
K802629
Cordis Corp.
Cardiovascular · 8d
Cleared Jun 30, 1980
PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE
K801321
Graphic Controls Corp.
Cardiovascular · 25d
Cleared Jun 30, 1980
MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS
K801322
Graphic Controls Corp.
Cardiovascular · 25d
Cleared Apr 29, 1980
EXTENSION LINE
K800622
Norton Performance Plastics Corp.
Cardiovascular · 42d
Cleared Apr 24, 1980
SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET
K800618
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 16, 1980
CENTRAL VEIN CATHETERIZATION KIT
K800741
Medical Components, Inc.
Cardiovascular · 13d
Cleared Mar 12, 1980
CENTRAL VENOUS PRESSURE CATHETER
K800461
Medical Components, Inc.
Cardiovascular · 12d
Cleared Dec 19, 1979
WHITE SEALING CAP
K791915
Quinton, Inc.
Cardiovascular · 85d
Cleared Jan 15, 1979
POST EXTRA SYSTOLIC POTENTIATOR
K781819
Medrad, Inc.
Cardiovascular · 80d
Cleared Dec 20, 1978
CATHETER, DIGITAL POSITRAL II
K782082
C.R. Bard, Inc.
Cardiovascular · 6d