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
Feb 01, 2008
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
Vascular Solutions, Inc.
Cardiovascular
80d
Cleared
Dec 18, 2007
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
Concentric Medical, Inc.
Cardiovascular
78d
Cleared
Apr 16, 2007
DYE MANAGEMENT SYSTEM
Icu Medical, Inc.
Cardiovascular
116d
Cleared
Jan 18, 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
Vascular Solutions, Inc.
Cardiovascular
114d
Cleared
Jan 05, 2007
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
Vascular Solutions, Inc.
Cardiovascular
122d
Cleared
Nov 30, 2006
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
Boston Scientific Corp
Radiology
28d
Cleared
Aug 24, 2006
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
AngioDynamics, Inc.
Cardiovascular
65d
Cleared
Aug 02, 2006
LANGSTON DUAL LUMEN CATHETER
Vascular Solutions, Inc.
Cardiovascular
58d
Cleared
Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
Boston Scientific Corp
Cardiovascular
60d
Cleared
Jan 19, 2006
MERIT IMPRESS DIAGNOSTIC CATHETER
Merit Medical Systems, Inc.
Cardiovascular
66d
Cleared
Dec 22, 2005
HOSPIRA CATH LAB CONVENIENCE KITS
Icu Medical, Inc.
Cardiovascular
72d
Cleared
Nov 02, 2005
ASAHI ANGIOGRAPHIC CATHETER
Asahi Intecc Co., Ltd.
Cardiovascular
142d
Cleared
Sep 02, 2005
IMAGER II ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
150d
Cleared
Jun 24, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
Vascular Solutions, Inc.
Cardiovascular
28d
Cleared
Jun 07, 2005
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
Medrad, Inc.
Cardiovascular
113d
Cleared
May 20, 2005
ATLANTIS PV
Boston Scientific Corp
Radiology
64d
Cleared
May 18, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
Vascular Solutions, Inc.
Cardiovascular
112d
Cleared
Mar 30, 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
Boston Scientific Corp
Cardiovascular
23d
Cleared
Sep 23, 2004
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
Vascular Solutions, Inc.
Cardiovascular
70d
Cleared
Jun 18, 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
NuMED, Inc.
Cardiovascular
79d
Cleared
Apr 29, 2004
ATLANTIS SR, MODEL C4020
Boston Scientific Corp
Cardiovascular
34d
Cleared
Dec 12, 2003
PROGREAT
Terumo Medical Corp.
Cardiovascular
29d
Cleared
Aug 26, 2003
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
AngioDynamics, Inc.
Cardiovascular
25d
Cleared
Jun 18, 2003
ULTRA HIGH PRESSURE INJECTOR LINES
Deroyal Industries, Inc.
Cardiovascular
236d