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 18, 1991
ACS ANGIOSCOPIC CATHETER
Advanced Cardiovascular Systems, Inc.
Cardiovascular
87d
Cleared
Feb 21, 1991
CVIS INSIGHT IMAGING CATHETER
Cardiovascular Imaging Systems, Inc.
Cardiovascular
69d
Cleared
Feb 11, 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
Scimed Life Systems, Inc.
Cardiovascular
66d
Cleared
Feb 01, 1991
TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
Lifestream Int'L, Inc.
Cardiovascular
122d
Cleared
Feb 01, 1991
DIAVENTIONAL CATHETER
Cordis Corp.
Cardiovascular
66d
Cleared
Feb 01, 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
C.R. Bard, Inc.
Cardiovascular
39d
Cleared
Dec 17, 1990
HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
Medex, Inc.
Cardiovascular
150d
Cleared
Dec 17, 1990
MEWISSEN CATHETER
Boston Scientific Corp
Cardiovascular
55d
Cleared
Dec 17, 1990
PSG HEMOSTATIC CONTROL VALVE
Peripheral Systems Group
Cardiovascular
42d
Cleared
Nov 05, 1990
ARTERIAL BLOOD SAMPLING KIT
Medex, Inc.
Cardiovascular
137d
Cleared
Sep 28, 1990
SOFTOUCH GUIDING CATHETER
Mallinckrodt Medical
Cardiovascular
85d
Cleared
Jul 06, 1990
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
Cardiovascular Imaging Systems, Inc.
Cardiovascular
87d
Cleared
Jun 28, 1990
SCIMED CORONARY GUIDING CATHETER
Scimed Life Systems, Inc.
Cardiovascular
293d
Cleared
Apr 23, 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
C.R. Bard, Inc.
Cardiovascular
256d
Cleared
Apr 06, 1990
SONICATH(TM) 5 F
Boston Scientific Corp
Cardiovascular
205d
Cleared
Mar 28, 1990
CORDIS SHUTTLE CATHETER
Cordis Corp.
Cardiovascular
147d
Cleared
Feb 28, 1990
SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
Schneider Intl., Ltd.
Cardiovascular
90d
Cleared
Jan 19, 1990
GUIDING CATHETER
Peripheral Systems Group
Cardiovascular
150d
Cleared
Dec 28, 1989
MULTILUMEN CENTRAL VENOUS CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular
373d
Cleared
Dec 20, 1989
BIOCHEM 3100 OXIMETER
Biochem International, Inc.
Cardiovascular
208d
Cleared
Nov 27, 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
Baxter Healthcare Corp
Cardiovascular
165d
Cleared
Nov 06, 1989
ARROW HANDS-OFF THERMO-PACE
Arrow Intl., Inc.
Cardiovascular
75d
Cleared
Aug 03, 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
Boston Scientific Corp
Cardiovascular
136d
Cleared
May 19, 1989
E-Z-FLOW ANGIOGRAPHY CATHETERS
E-Z-Em, Inc.
Cardiovascular
122d