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
193–216 of 501
Cleared Dec 18, 1991
MERIT DISPOSAL DEPOT(TM)
K914208
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Dec 10, 1991
RETRIEVAL DEVICE
K914067
Target Therapeutics
Cardiovascular · 90d
Cleared Nov 25, 1991
FLOSWITCH(R) HP
K913871
Boston Scientific Corp
Cardiovascular · 89d
Cleared Nov 22, 1991
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS
K914312
Scimed Life Systems, Inc.
Cardiovascular · 57d
Cleared Nov 15, 1991
MERIT CUSTOM KIT
K913682
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Oct 23, 1991
CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER
K914141
Cordis Corp.
Cardiovascular · 37d
Cleared Oct 18, 1991
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
K914007
Cordis Corp.
Cardiovascular · 39d
Cleared Sep 06, 1991
ACS RX SUPPORT CATHETER
K911957
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 127d
Cleared Aug 30, 1991
SCIMED 7 FR. & 8 FR.
K913364
Scimed Life Systems, Inc.
Cardiovascular · 32d
Cleared Jul 09, 1991
TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES
K911605
Target Therapeutics
Cardiovascular · 90d
Cleared Jul 05, 1991
ZEPHYR INFUSION CATHETER
K911560
Target Therapeutics
Cardiovascular · 88d
Cleared Jun 28, 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
K911703
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 10, 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367
Baxter Healthcare Corp
Cardiovascular · 74d
Cleared Apr 24, 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204
Baxter Healthcare Corp
Cardiovascular · 98d
Cleared Apr 01, 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208
Baxter Healthcare Corp
Cardiovascular · 75d
Cleared Mar 18, 1991
ACS ANGIOSCOPIC CATHETER
K905715
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
Cleared Feb 11, 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499
Scimed Life Systems, Inc.
Cardiovascular · 66d
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 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 Jun 28, 1990
SCIMED CORONARY GUIDING CATHETER
K895437
Scimed Life Systems, Inc.
Cardiovascular · 293d