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..

500
Total
500
Cleared
122d
Avg days
1976
Since
500 devices
49–72 of 500
Cleared Feb 19, 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276
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
K063312
Boston Scientific Corp
Radiology · 28d
Cleared Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175
Boston Scientific Corp
Cardiovascular · 60d
Cleared Sep 02, 2005
IMAGER II ANGIOGRAPHIC CATHETER
K050863
Boston Scientific Corp
Cardiovascular · 150d
Cleared May 20, 2005
ATLANTIS PV
K050684
Boston Scientific Corp
Radiology · 64d
Cleared Mar 30, 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
K050577
Boston Scientific Corp
Cardiovascular · 23d
Cleared Apr 29, 2004
ATLANTIS SR, MODEL C4020
K040776
Boston Scientific Corp
Cardiovascular · 34d
Cleared Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126
Abbott Laboratories
Cardiovascular · 29d
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681
Boston Scientific Corp
Cardiovascular · 25d
Cleared Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621
Boston Scientific Corp
Cardiovascular · 28d
Cleared Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
K020316
Cordis Corp.
Cardiovascular · 49d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217
Abbott Laboratories
Cardiovascular · 26d
Cleared May 03, 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579
Cordis Corp.
Cardiovascular · 71d
Cleared Oct 08, 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347
Cordis Corp.
Cardiovascular · 86d
Cleared May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673
Cordis Corp.
Cardiovascular · 9d
Cleared May 15, 1998
SITESEER ANGIOGRAPHIC CATHETER
K980575
C.R. Bard, Inc.
Cardiovascular · 87d
Cleared Nov 18, 1997
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401
Cordis Corp.
Cardiovascular · 70d
Cleared Oct 10, 1997
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
K965112
Medline Industries, Inc.
Cardiovascular · 294d
Cleared Sep 30, 1997
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
K970854
Cordis Corp.
Cardiovascular · 204d
Cleared Jul 31, 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
K970207
Boston Scientific Corp
Cardiovascular · 191d
Cleared Jul 24, 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607
Boston Scientific Corp
Cardiovascular · 84d
Cleared Jul 14, 1997
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
K971646
Cordis Corp.
Cardiovascular · 70d
Cleared May 28, 1997
USCI MAINSTAY GUIDING CATHETER
K971034
C.R. Bard, Inc.
Cardiovascular · 68d
Cleared Oct 23, 1996
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
K960056
C.R. Bard, Inc.
Cardiovascular · 293d