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
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
Nov 18, 2004
METRICATH SYSTEM
Angiometrx, Inc.
Cardiovascular
50d
Cleared
Sep 23, 2004
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
Vascular Solutions, Inc.
Cardiovascular
70d
Cleared
Aug 26, 2004
RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
Kerberos Proximal Solutions, Inc.
Cardiovascular
118d
Cleared
Jun 30, 2004
H-FLOW VALVE
Elcam Medical Acal
Cardiovascular
184d
Cleared
Jun 18, 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
NuMED, Inc.
Cardiovascular
79d
Cleared
May 21, 2004
RINSPIRATION SYSTEM
Kerberos Proximal Solutions, Inc.
Cardiovascular
7d
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
Cleared
Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
Abbott Laboratories
Cardiovascular
29d
Cleared
Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
Boston Scientific Corp
Cardiovascular
25d
Cleared
Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
28d
Cleared
May 02, 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
Guidant Corp.
Cardiovascular
14d
Cleared
Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
St Jude Medical
Cardiovascular
29d
Cleared
Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
Cordis Corp.
Cardiovascular
49d
Cleared
Mar 13, 2002
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
Acist Medical Systems, Inc.
Cardiovascular
189d
Cleared
Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
Edwards Lifesciences, LLC
Cardiovascular
88d
Cleared
May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
Concentric Medical, Inc.
Cardiovascular
225d
Cleared
May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
Abbott Laboratories
Cardiovascular
26d
Cleared
Mar 29, 2001
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
Boston Scientific, Target
Radiology
20d