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
145–168 of 501
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 Mar 01, 2000
MIKRO-TIP ANGIOGRAPHIC CATHETER
K993694
Millar Instruments, Inc.
Cardiovascular · 120d
Cleared Dec 21, 1999
PATHFINDER II ANGIOGRAPHIC CATHETER
K990173
Maxxim Medical
Cardiovascular · 336d
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 Jul 27, 1999
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
K984627
Arterial Vascular Engineering, Inc.
Cardiovascular · 209d
Cleared Jul 21, 1999
SCIMED ANGIOGRAPHIC CATHETERS
K992142
Scimed
Cardiovascular · 27d
Cleared May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673
Cordis Corp.
Cardiovascular · 9d
Cleared Feb 11, 1999
NEUROVASX SUB-MICROINFUSION CATHETER
K984258
Neuro Vasx, Inc.
Cardiovascular · 73d
Cleared Dec 10, 1998
MEDTRONIC ANGIOGRAPHIC CATHETER
K980973
Medtronics Interventional Vascular
Cardiovascular · 269d
Cleared Nov 04, 1998
BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
K971616
Data Sciences Intl., Inc.
Cardiovascular · 551d
Cleared Oct 19, 1998
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299
Daig Corp.
Cardiovascular · 110d
Cleared Oct 16, 1998
ENVY GUIDING CATHETER
K974774
Cook, Inc.
Cardiovascular · 298d
Cleared Aug 18, 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
K981788
Scimed Life Systems, Inc.
Cardiovascular · 90d