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
121–144 of 501
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
Cleared Aug 11, 1998
SELECTOR DIAGNOSTIC CATHETER
K982077
Boston Scientific Scimed, Inc.
Cardiovascular · 60d
Cleared Jul 10, 1998
HEART CATH TRAY, STERILE, DISPOSABLE
K981441
Trinity Laboratories, Inc.
Cardiovascular · 80d
Cleared May 15, 1998
SITESEER ANGIOGRAPHIC CATHETER
K980575
C.R. Bard, Inc.
Cardiovascular · 87d
Cleared Feb 23, 1998
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K974559
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Nov 18, 1997
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401
Cordis Corp.
Cardiovascular · 70d
Cleared Oct 31, 1997
RETRIEVER II
K964210
Target Therapeutics
Cardiovascular · 374d
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 May 06, 1997
3F ANGIOPTIC ANGIOGRAPHIC CATHETER
K964033
AngioDynamics, Inc.
Cardiovascular · 210d
Cleared Feb 21, 1997
SPYGLASS ANGIOGRAPHIC CATHETER
K965249
Daig Corp.
Cardiovascular · 71d
Cleared Feb 10, 1997
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K964859
Scimed Life Systems, 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
Cleared Oct 17, 1996
LAGUNA SOFTIP DIAGNOSTIC CATHETERS
K961499
Boston Scientific Scimed, Inc.
Cardiovascular · 182d
Cleared Oct 15, 1996
SPYGLASS ANGIOGRAPHIC CATHETER
K962805
Daig Corp.
Cardiovascular · 89d
Cleared Oct 10, 1996
4F NYLEX ANGIOGRAPHIC CATHETER
K962759
Cordis Corp.
Cardiovascular · 86d
Cleared May 02, 1996
TURBO TRACKER
K960806
Target Therapeutics
Cardiovascular · 64d
Cleared Apr 02, 1996
NUMED ATRIOSEPTOSTOMY CATHETER
K960070
NuMED, Inc.
Cardiovascular · 88d
Cleared Apr 02, 1996
1-4F INFINITI ANGIOGRAPHIC CATHETER
K960975
Cordis Corp.
Cardiovascular · 22d