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..

500
Total
500
Cleared
122d
Avg days
1976
Since
500 devices
73–96 of 500
Cleared Oct 10, 1996
4F NYLEX ANGIOGRAPHIC CATHETER
K962759
Cordis Corp.
Cardiovascular · 86d
Cleared Apr 02, 1996
1-4F INFINITI ANGIOGRAPHIC CATHETER
K960975
Cordis Corp.
Cardiovascular · 22d
Cleared Sep 12, 1995
EVOLUTION MICROCATHETER
K953114
Boston Scientific Corp
Cardiovascular · 71d
Cleared Jun 13, 1995
0.035 IN. WISE WIRE
K942927
Boston Scientific Corp
Radiology · 356d
Cleared Dec 13, 1994
HIGH PRESSURE TUBING
K941978
Abbott Laboratories
Cardiovascular · 243d
Cleared Sep 22, 1994
CARDIAC CATHETERIZATION KIT
K932141
Abbott Laboratories
Cardiovascular · 518d
Cleared Aug 31, 1994
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM
K942939
Cordis Corp.
Cardiovascular · 70d
Cleared Jun 20, 1994
HAND CONTROLLED SYRINGE
K942329
Abbott Laboratories
Cardiovascular · 35d
Cleared Jun 13, 1994
DYE MANAGEMENT SYSTEM
K941254
Abbott Laboratories
Cardiovascular · 94d
Cleared May 31, 1994
TRANSIT INFUSION CATHETER
K936260
Cordis Corp.
Cardiovascular · 152d
Cleared Nov 03, 1993
DYE MANAGEMENT SYSTEM
K933700
Abbott Laboratories
Cardiovascular · 97d
Cleared Jul 29, 1993
USCI ANGIOGRAPHIC CATHETER
K932092
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jun 23, 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891
Cordis Corp.
Cardiovascular · 372d
Cleared Apr 21, 1993
NYLEX CATHETERS
K930479
Cordis Corp.
Cardiovascular · 82d
Cleared Nov 17, 1992
USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING
K922105
C.R. Bard, Inc.
Cardiovascular · 195d
Cleared Sep 21, 1992
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
K915726
Baxter Healthcare Corp
Cardiovascular · 276d
Cleared Sep 17, 1992
CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER
K921310
Cordis Corp.
Cardiovascular · 182d
Cleared Aug 24, 1992
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT
K920980
C.R. Bard, Inc.
Cardiovascular · 175d
Cleared Jun 03, 1992
CARDIAC CATHERIZATION KIT
K914299
Abbott Laboratories
Cardiovascular · 252d
Cleared Apr 17, 1992
CORDIS ANGIOGRAPHIC DOPPLER CATHER
K915498
Cordis Corp.
Cardiovascular · 130d
Cleared Apr 07, 1992
DESERET GUIDEWIRE INTRODUCER II
K920407
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 67d
Cleared Apr 07, 1992
DESERET GUIDEWIRE INTRODUCER III
K920408
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 67d
Cleared Feb 11, 1992
CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS
K915836
Cordis Corp.
Cardiovascular · 49d
Cleared Nov 25, 1991
FLOSWITCH(R) HP
K913871
Boston Scientific Corp
Cardiovascular · 89d