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..

501
Total
501
Cleared
122d
Avg days
1976
Since
501 devices
97–120 of 501
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 May 02, 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
K021283
Guidant Corp.
Cardiovascular · 14d
Cleared Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
K020890
St Jude Medical
Cardiovascular · 29d
Cleared Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
K020316
Cordis Corp.
Cardiovascular · 49d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
K014054
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217
Abbott Laboratories
Cardiovascular · 26d
Cleared Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
K002254
Cook, Inc.
Cardiovascular · 234d
Cleared Jan 17, 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared Jan 11, 2001
MULTITRACK ANGIOGRAPHIC CATHETER
K003902
NuMED, Inc.
Cardiovascular · 23d
Cleared Oct 13, 2000
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578
AngioDynamics, Inc.
Cardiovascular · 144d
Cleared Sep 11, 2000
GOLDEN-RULE SCALING CATHETER
K002416
Medical Device Technologies, Inc.
Cardiovascular · 34d
Cleared Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
K000743
Boston Scientific Scimed, Inc.
Cardiovascular · 183d
Cleared May 03, 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579
Cordis Corp.
Cardiovascular · 71d
Cleared Apr 21, 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
K000956
Boston Scientific Scimed, Inc.
Cardiovascular · 28d
Cleared Mar 29, 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Dec 15, 1999
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631
Acuson Corp.
Radiology · 131d
Cleared Oct 08, 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347
Cordis Corp.
Cardiovascular · 86d
Cleared Aug 23, 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K992123
Boston Scientific Scimed, Inc.
Cardiovascular · 61d
Cleared Aug 10, 1999
RADIFOCUS OPTITORQUE
K992051
Terumo Medical Corp.
Cardiovascular · 53d
Cleared May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673
Cordis Corp.
Cardiovascular · 9d
Cleared Oct 19, 1998
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299
Daig Corp.
Cardiovascular · 110d