DQO · Class II · 21 CFR 870.1200

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
289–312 of 501
Cleared Mar 18, 1991
ACS ANGIOSCOPIC CATHETER
K905715
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
Cleared Feb 21, 1991
CVIS INSIGHT IMAGING CATHETER
K905625
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 69d
Cleared Feb 11, 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499
Scimed Life Systems, Inc.
Cardiovascular · 66d
Cleared Feb 01, 1991
TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
K904491
Lifestream Int'L, Inc.
Cardiovascular · 122d
Cleared Feb 01, 1991
DIAVENTIONAL CATHETER
K905297
Cordis Corp.
Cardiovascular · 66d
Cleared Feb 01, 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727
C.R. Bard, Inc.
Cardiovascular · 39d
Cleared Dec 17, 1990
HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
K903199
Medex, Inc.
Cardiovascular · 150d
Cleared Dec 17, 1990
MEWISSEN CATHETER
K904788
Boston Scientific Corp
Cardiovascular · 55d
Cleared Dec 17, 1990
PSG HEMOSTATIC CONTROL VALVE
K904959
Peripheral Systems Group
Cardiovascular · 42d
Cleared Nov 05, 1990
ARTERIAL BLOOD SAMPLING KIT
K902771
Medex, Inc.
Cardiovascular · 137d
Cleared Sep 28, 1990
SOFTOUCH GUIDING CATHETER
K902953
Mallinckrodt Medical
Cardiovascular · 85d
Cleared Jul 06, 1990
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
K901691
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Jun 28, 1990
SCIMED CORONARY GUIDING CATHETER
K895437
Scimed Life Systems, Inc.
Cardiovascular · 293d
Cleared Apr 23, 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180
C.R. Bard, Inc.
Cardiovascular · 256d
Cleared Apr 06, 1990
SONICATH(TM) 5 F
K895542
Boston Scientific Corp
Cardiovascular · 205d
Cleared Mar 28, 1990
CORDIS SHUTTLE CATHETER
K896308
Cordis Corp.
Cardiovascular · 147d
Cleared Feb 28, 1990
SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
K896741
Schneider Intl., Ltd.
Cardiovascular · 90d
Cleared Jan 19, 1990
GUIDING CATHETER
K895146
Peripheral Systems Group
Cardiovascular · 150d
Cleared Dec 28, 1989
MULTILUMEN CENTRAL VENOUS CATHETER
K885221
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 373d
Cleared Dec 20, 1989
BIOCHEM 3100 OXIMETER
K893877
Biochem International, Inc.
Cardiovascular · 208d
Cleared Nov 27, 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168
Baxter Healthcare Corp
Cardiovascular · 165d
Cleared Nov 06, 1989
ARROW HANDS-OFF THERMO-PACE
K895268
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Aug 03, 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580
Boston Scientific Corp
Cardiovascular · 136d
Cleared May 19, 1989
E-Z-FLOW ANGIOGRAPHY CATHETERS
K890206
E-Z-Em, Inc.
Cardiovascular · 122d