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
Cleared
Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
Cook, Inc.
Cardiovascular
234d
Cleared
Jan 17, 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
AngioDynamics, Inc.
Cardiovascular
30d
Cleared
Jan 11, 2001
MULTITRACK ANGIOGRAPHIC CATHETER
NuMED, Inc.
Cardiovascular
23d
Cleared
Oct 13, 2000
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
AngioDynamics, Inc.
Cardiovascular
144d
Cleared
Sep 11, 2000
GOLDEN-RULE SCALING CATHETER
Medical Device Technologies, Inc.
Cardiovascular
34d
Cleared
Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
Boston Scientific Scimed, Inc.
Cardiovascular
183d
Cleared
May 03, 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
Cordis Corp.
Cardiovascular
71d
Cleared
Apr 21, 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
Boston Scientific Scimed, Inc.
Cardiovascular
28d
Cleared
Mar 29, 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
Merit Medical Systems, Inc.
Cardiovascular
30d
Cleared
Mar 01, 2000
MIKRO-TIP ANGIOGRAPHIC CATHETER
Millar Instruments, Inc.
Cardiovascular
120d
Cleared
Dec 21, 1999
PATHFINDER II ANGIOGRAPHIC CATHETER
Maxxim Medical
Cardiovascular
336d
Cleared
Dec 15, 1999
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
Acuson Corp.
Radiology
131d
Cleared
Oct 08, 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
Cordis Corp.
Cardiovascular
86d
Cleared
Aug 23, 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
Boston Scientific Scimed, Inc.
Cardiovascular
61d
Cleared
Aug 10, 1999
RADIFOCUS OPTITORQUE
Terumo Medical Corp.
Cardiovascular
53d
Cleared
Jul 27, 1999
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
Arterial Vascular Engineering, Inc.
Cardiovascular
209d
Cleared
Jul 21, 1999
SCIMED ANGIOGRAPHIC CATHETERS
Scimed
Cardiovascular
27d
Cleared
May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
Cordis Corp.
Cardiovascular
9d
Cleared
Feb 11, 1999
NEUROVASX SUB-MICROINFUSION CATHETER
Neuro Vasx, Inc.
Cardiovascular
73d
Cleared
Dec 10, 1998
MEDTRONIC ANGIOGRAPHIC CATHETER
Medtronics Interventional Vascular
Cardiovascular
269d
Cleared
Nov 04, 1998
BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
Data Sciences Intl., Inc.
Cardiovascular
551d
Cleared
Oct 19, 1998
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
Daig Corp.
Cardiovascular
110d
Cleared
Oct 16, 1998
ENVY GUIDING CATHETER
Cook, Inc.
Cardiovascular
298d
Cleared
Aug 18, 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
Scimed Life Systems, Inc.
Cardiovascular
90d