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
337–360 of 501
Cleared May 15, 1986
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)
K861483
Mallinckrodt Critical Care
Cardiovascular · 28d
Cleared May 08, 1986
PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
K860805
Gould, Inc.
Cardiovascular · 65d
Cleared Apr 23, 1986
MEADOX SURGIMED GUIDE CATHETER
K860429
Meadox Surgimed, Inc.
Cardiovascular · 78d
Cleared Mar 31, 1986
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
K860580
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Feb 26, 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576
Cordis Corp.
Cardiovascular · 105d
Cleared Jan 15, 1986
DIAGNOSTIC INTRAVASCULAR CATHETERS
K853182
Mallinckrodt Critical Care
Cardiovascular · 169d
Cleared Nov 06, 1985
LAP-CATH
K852197
Research Medical, Inc.
Cardiovascular · 170d
Cleared Nov 01, 1985
FAP-CATH
K852456
Research Medical, Inc.
Cardiovascular · 144d
Cleared May 21, 1985
OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT
K844854
Vas-Cath of Canada , Ltd.
Cardiovascular · 159d
Cleared May 16, 1985
OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS
K844800
Vas-Cath of Canada , Ltd.
Cardiovascular · 156d
Cleared May 16, 1985
UMI ANGIOGRAPHIC CATHETER
K851088
Universal Medical Instrument Corp.
Cardiovascular · 59d
Cleared Mar 27, 1985
PATHFINDER CARDIOVASCULAR CATHETER
K844555
Argon Medical Corp.
Cardiovascular · 126d
Cleared Feb 01, 1985
LARIAT CATHETER
K844598
Mallinckrodt Critical Care
Cardiovascular · 67d
Cleared Jan 02, 1985
PTCA GUIDING CATHER
K844161
Cordis Corp.
Cardiovascular · 71d
Cleared Oct 18, 1984
NAMIC ADB ANGIOGRAPHIC DUMP BAG
K843726
North American Instrument Corp.
Cardiovascular · 24d
Cleared Aug 10, 1984
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798
American Edwards Laboratories
Cardiovascular · 24d
Cleared Aug 10, 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
K842799
American Edwards Laboratories
Cardiovascular · 24d
Cleared Jul 13, 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 39d
Cleared Jun 05, 1984
ELECATH HEPARIN-COATED CATHETERS
K841615
Electro-Catheter Corp.
Cardiovascular · 64d
Cleared Feb 04, 1984
DIAGNOSTIC RADIOLOGY CATHETERS
K834459
American Edwards Laboratories
Cardiovascular · 47d
Cleared Oct 19, 1983
PERCLUDER DL OCCLUDING BALLOON
K832386
Datascope Corp.
Cardiovascular · 92d
Cleared Jul 19, 1983
COMPRESSAR DISPOSABLE DISC
K831337
Instromedix, Inc.
Cardiovascular · 85d
Cleared Jun 08, 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509
Mallinckrodt Critical Care
Cardiovascular · 28d
Cleared May 25, 1983
DIGICATH
K831171
Argon Medical Corp.
Cardiovascular · 44d