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
Cleared
Aug 28, 1986
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
Shiley, Inc.
Cardiovascular
59d
Cleared
Aug 25, 1986
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS
Cordis Corp.
Cardiovascular
74d
Cleared
Aug 11, 1986
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
Shiley, Inc.
Cardiovascular
42d
Cleared
Jul 10, 1986
ACS CORONARY GUIDING CATHETER
Advanced Cardiovascular Systems, Inc.
Cardiovascular
99d
Cleared
Jul 02, 1986
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
Medical Components, Inc.
Cardiovascular
117d
Cleared
Jun 27, 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
Cordis Corp.
Cardiovascular
31d
Cleared
May 15, 1986
ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)
Mallinckrodt Critical Care
Cardiovascular
28d
Cleared
Mar 31, 1986
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
Advanced Cardiovascular Systems, Inc.
Cardiovascular
41d
Cleared
Feb 26, 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
Cordis Corp.
Cardiovascular
105d
Cleared
Jan 15, 1986
DIAGNOSTIC INTRAVASCULAR CATHETERS
Mallinckrodt Critical Care
Cardiovascular
169d
Cleared
Nov 06, 1985
LAP-CATH
Research Medical, Inc.
Cardiovascular
170d
Cleared
Nov 01, 1985
FAP-CATH
Research Medical, Inc.
Cardiovascular
144d
Cleared
Feb 01, 1985
LARIAT CATHETER
Mallinckrodt Critical Care
Cardiovascular
67d
Cleared
Jan 02, 1985
PTCA GUIDING CATHER
Cordis Corp.
Cardiovascular
71d
Cleared
Aug 10, 1984
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
American Edwards Laboratories
Cardiovascular
24d
Cleared
Aug 10, 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
American Edwards Laboratories
Cardiovascular
24d
Cleared
Jul 13, 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
Advanced Cardiovascular Systems, Inc.
Cardiovascular
39d
Cleared
Jun 05, 1984
ELECATH HEPARIN-COATED CATHETERS
Electro-Catheter Corp.
Cardiovascular
64d
Cleared
Feb 04, 1984
DIAGNOSTIC RADIOLOGY CATHETERS
American Edwards Laboratories
Cardiovascular
47d
Cleared
Oct 19, 1983
PERCLUDER DL OCCLUDING BALLOON
Datascope Corp.
Cardiovascular
92d
Cleared
Jun 08, 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
Mallinckrodt Critical Care
Cardiovascular
28d
Cleared
May 09, 1983
ANGIOGRAPHIC NEEDLE
Medrad, Inc.
Cardiovascular
27d
Cleared
Apr 30, 1983
CENTRAL VEIN CATHERIZATION KIT-14-690-
Norton Performance Plastics Corp.
Cardiovascular
47d
Cleared
Apr 28, 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
Mallinckrodt Critical Care
Cardiovascular
79d