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