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
Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
Abbott Laboratories
Cardiovascular
29d
Cleared
Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
Boston Scientific Corp
Cardiovascular
25d
Cleared
Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
28d
Cleared
May 02, 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
Guidant Corp.
Cardiovascular
14d
Cleared
Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
St Jude Medical
Cardiovascular
29d
Cleared
Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
Cordis Corp.
Cardiovascular
49d
Cleared
Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
Edwards Lifesciences, LLC
Cardiovascular
88d
Cleared
May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
Concentric Medical, Inc.
Cardiovascular
225d
Cleared
May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
Abbott Laboratories
Cardiovascular
26d
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
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
May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
Cordis Corp.
Cardiovascular
9d
Cleared
Oct 19, 1998
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
Daig Corp.
Cardiovascular
110d