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..
500
Total
500
Cleared
122d
Avg days
1976
Since
500 devices
Cleared
Feb 19, 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
15d
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
Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
Boston Scientific Corp
Cardiovascular
60d
Cleared
Sep 02, 2005
IMAGER II ANGIOGRAPHIC CATHETER
Boston Scientific Corp
Cardiovascular
150d
Cleared
May 20, 2005
ATLANTIS PV
Boston Scientific Corp
Radiology
64d
Cleared
Mar 30, 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
Boston Scientific Corp
Cardiovascular
23d
Cleared
Apr 29, 2004
ATLANTIS SR, MODEL C4020
Boston Scientific Corp
Cardiovascular
34d
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
Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
Cordis Corp.
Cardiovascular
49d
Cleared
May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
Abbott Laboratories
Cardiovascular
26d
Cleared
May 03, 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
Cordis Corp.
Cardiovascular
71d
Cleared
Oct 08, 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
Cordis Corp.
Cardiovascular
86d
Cleared
May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
Cordis Corp.
Cardiovascular
9d
Cleared
May 15, 1998
SITESEER ANGIOGRAPHIC CATHETER
C.R. Bard, Inc.
Cardiovascular
87d
Cleared
Nov 18, 1997
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
Cordis Corp.
Cardiovascular
70d
Cleared
Oct 10, 1997
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
Medline Industries, Inc.
Cardiovascular
294d
Cleared
Sep 30, 1997
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
Cordis Corp.
Cardiovascular
204d
Cleared
Jul 31, 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
Boston Scientific Corp
Cardiovascular
191d
Cleared
Jul 24, 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
Boston Scientific Corp
Cardiovascular
84d
Cleared
Jul 14, 1997
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
Cordis Corp.
Cardiovascular
70d
Cleared
May 28, 1997
USCI MAINSTAY GUIDING CATHETER
C.R. Bard, Inc.
Cardiovascular
68d
Cleared
Oct 23, 1996
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
C.R. Bard, Inc.
Cardiovascular
293d