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
241–264 of 501
Cleared Aug 28, 1986
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
K862464
Shiley, Inc.
Cardiovascular · 59d
Cleared Aug 25, 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
K862244
Cordis Corp.
Cardiovascular · 74d
Cleared Aug 11, 1986
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
K862465
Shiley, Inc.
Cardiovascular · 42d
Cleared Jul 10, 1986
ACS CORONARY GUIDING CATHETER
K861236
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 99d
Cleared Jul 02, 1986
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
K860867
Medical Components, Inc.
Cardiovascular · 117d
Cleared Jun 27, 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006
Cordis Corp.
Cardiovascular · 31d
Cleared May 15, 1986
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)
K861483
Mallinckrodt Critical Care
Cardiovascular · 28d
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 Feb 01, 1985
LARIAT CATHETER
K844598
Mallinckrodt Critical Care
Cardiovascular · 67d
Cleared Jan 02, 1985
PTCA GUIDING CATHER
K844161
Cordis Corp.
Cardiovascular · 71d
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 Jun 08, 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509
Mallinckrodt Critical Care
Cardiovascular · 28d
Cleared May 09, 1983
ANGIOGRAPHIC NEEDLE
K831189
Medrad, Inc.
Cardiovascular · 27d
Cleared Apr 30, 1983
CENTRAL VEIN CATHERIZATION KIT-14-690-
K830788
Norton Performance Plastics Corp.
Cardiovascular · 47d
Cleared Apr 28, 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415
Mallinckrodt Critical Care
Cardiovascular · 79d