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
265–288 of 501
Cleared Jan 27, 1992
DISPOSABLE SLIDE VALVE MANIFOLD
K913094
Professional Medical Services
Cardiovascular · 199d
Cleared Dec 18, 1991
ANGIOGRAPHIC SOFT TIP CATHETER
K914199
E-Z-Em, Inc.
Cardiovascular · 90d
Cleared Dec 18, 1991
MERIT DISPOSAL DEPOT(TM)
K914208
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Dec 11, 1991
ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH
K912532
Interventional Therapeutics Corp.
Cardiovascular · 187d
Cleared Dec 10, 1991
RETRIEVAL DEVICE
K914067
Target Therapeutics
Cardiovascular · 90d
Cleared Dec 06, 1991
SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER
K914009
Schneider Intl., Ltd.
Cardiovascular · 88d
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 Nov 05, 1991
ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION
K912477
Interventional Therapeutics Corp.
Cardiovascular · 154d
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 22, 1991
PRESSURE MONITORING EXTENSION LINE
K910378
Professional Medical Services
Cardiovascular · 83d
Cleared Apr 18, 1991
SCHNEIDER MAGNARAIL PROBING CATHETER
K910259
Schneider Intl., Ltd.
Cardiovascular · 86d
Cleared Apr 12, 1991
CVIS INSIGHT IMAGING CATHETER
K904618
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 183d
Cleared Apr 01, 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208
Baxter Healthcare Corp
Cardiovascular · 75d
Cleared Mar 25, 1991
DIAGNOSTIC INTRASCULAR CATHETER
K903848
Applied Vascular Devices, Inc.
Cardiovascular · 216d