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
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
Cleared
Aug 11, 1998
SELECTOR DIAGNOSTIC CATHETER
Boston Scientific Scimed, Inc.
Cardiovascular
60d
Cleared
Jul 10, 1998
HEART CATH TRAY, STERILE, DISPOSABLE
Trinity Laboratories, Inc.
Cardiovascular
80d
Cleared
May 15, 1998
SITESEER ANGIOGRAPHIC CATHETER
C.R. Bard, Inc.
Cardiovascular
87d
Cleared
Feb 23, 1998
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
Scimed Life Systems, Inc.
Cardiovascular
80d
Cleared
Nov 18, 1997
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
Cordis Corp.
Cardiovascular
70d
Cleared
Oct 31, 1997
RETRIEVER II
Target Therapeutics
Cardiovascular
374d
Cleared
Oct 10, 1997
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
Medline Industries, Inc.
Cardiovascular
294d
Cleared
Sep 30, 1997
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
Cordis Corp.
Cardiovascular
204d
Cleared
Jul 31, 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
Boston Scientific Corp
Cardiovascular
191d
Cleared
Jul 24, 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
Boston Scientific Corp
Cardiovascular
84d
Cleared
Jul 14, 1997
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
Cordis Corp.
Cardiovascular
70d
Cleared
May 28, 1997
USCI MAINSTAY GUIDING CATHETER
C.R. Bard, Inc.
Cardiovascular
68d
Cleared
May 06, 1997
3F ANGIOPTIC ANGIOGRAPHIC CATHETER
AngioDynamics, Inc.
Cardiovascular
210d
Cleared
Feb 21, 1997
SPYGLASS ANGIOGRAPHIC CATHETER
Daig Corp.
Cardiovascular
71d
Cleared
Feb 10, 1997
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
Scimed Life Systems, Inc.
Cardiovascular
68d
Cleared
Oct 23, 1996
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
C.R. Bard, Inc.
Cardiovascular
293d
Cleared
Oct 17, 1996
LAGUNA SOFTIP DIAGNOSTIC CATHETERS
Boston Scientific Scimed, Inc.
Cardiovascular
182d
Cleared
Oct 15, 1996
SPYGLASS ANGIOGRAPHIC CATHETER
Daig Corp.
Cardiovascular
89d
Cleared
Oct 10, 1996
4F NYLEX ANGIOGRAPHIC CATHETER
Cordis Corp.
Cardiovascular
86d
Cleared
May 02, 1996
TURBO TRACKER
Target Therapeutics
Cardiovascular
64d
Cleared
Apr 02, 1996
NUMED ATRIOSEPTOSTOMY CATHETER
NuMED, Inc.
Cardiovascular
88d
Cleared
Apr 02, 1996
1-4F INFINITI ANGIOGRAPHIC CATHETER
Cordis Corp.
Cardiovascular
22d