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
385–408 of 501
Cleared Nov 16, 1981
PET POLYETHYLENE TORQUE CATHETER
K812999
Universal Medical Instrument Corp.
Cardiovascular · 21d
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 Feb 01, 1979
CATHETER TUBING MODIFICATION
K790107
Jelco Laboratories
Cardiovascular · 16d
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
Cleared Oct 10, 1978
PRESSURE MONITORING INJECTION LINES
K781558
Cobe Laboratories, Inc.
Cardiovascular · 29d
Cleared May 09, 1978
MYOCATH KIT
K780529
Sorensen Research
Cardiovascular · 36d
Cleared Nov 17, 1977
PRESSURE TUBING
K771810
Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular · 51d
Cleared Jun 27, 1977
CATHETER, POLYURETHANE, W/STYLET
K770868
Abbott Laboratories
Cardiovascular · 46d
Cleared Mar 15, 1977
MONITORING KIT, CENTRAL VENOUS PRESSURE
K770290
Argon Medical Corp.
Cardiovascular · 29d
Cleared Mar 14, 1977
PUNCTURE KIT, INTERNAL JUGULAR
K770462
Arrow Intl., Inc.
Cardiovascular · 5d