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 Scimed Life Systems, Inc..

501
Total
501
Cleared
122d
Avg days
1976
Since
501 devices
217–240 of 501
Cleared Aug 31, 1994
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM
K942939
Cordis Corp.
Cardiovascular · 70d
Cleared Aug 01, 1994
MICROVIEW II/MICRORAIL II CATHETERS
K942231
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Jul 18, 1994
TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
K936282
Cordis Neurovascular, Inc.
Cardiovascular · 200d
Cleared Jul 11, 1994
CARDIAC CATHETERIZATION TRAY
K931560
Clinipad Corp.
Cardiovascular · 468d
Cleared Jun 20, 1994
HAND CONTROLLED SYRINGE
K942329
Abbott Laboratories
Cardiovascular · 35d
Cleared Jun 14, 1994
PRESSURE MONITORING EXTENSION
K942482
Surgical Technologies, Inc.
Cardiovascular · 20d
Cleared Jun 13, 1994
DYE MANAGEMENT SYSTEM
K941254
Abbott Laboratories
Cardiovascular · 94d
Cleared May 31, 1994
TRANSIT INFUSION CATHETER
K936260
Cordis Corp.
Cardiovascular · 152d
Cleared May 12, 1994
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
K934541
Scimed Life Systems, Inc.
Cardiovascular · 238d
Cleared May 12, 1994
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K935403
J-Lloyd Medical, Inc.
Cardiovascular · 184d
Cleared Apr 26, 1994
ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD
K935402
J-Lloyd Medical, Inc.
Cardiovascular · 168d
Cleared Mar 31, 1994
SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
K934581
Scimed Life Systems, Inc.
Cardiovascular · 189d
Cleared Mar 23, 1994
DIAGNOSTIC INTRAVASCULAR CATHETER
K925813
Target Therapeutics
Cardiovascular · 491d
Cleared Feb 22, 1994
SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH
K935654
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Dec 06, 1993
CARAPACE ANGIOGRAPHY TRAYS
K931629
Carapace, Inc.
Cardiovascular · 248d
Cleared Nov 03, 1993
DYE MANAGEMENT SYSTEM
K933700
Abbott Laboratories
Cardiovascular · 97d
Cleared Oct 06, 1993
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K931479
Mallinckrodt Medical
Cardiovascular · 196d
Cleared Aug 27, 1993
CARDIAC CATH OR ANGIOGRAPHIC TRAYS
K932218
Associated Medical Products Co.
Cardiovascular · 112d
Cleared Aug 17, 1993
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
K932420
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Aug 16, 1993
ANGIOGRAPHIC CATHETER
K926243
Target Therapeutics
Cardiovascular · 248d
Cleared Aug 11, 1993
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Jul 29, 1993
USCI ANGIOGRAPHIC CATHETER
K932092
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jul 21, 1993
CVIS INSIGHT IMAGING GUIDE CATHETER
K930232
Cardiovascular Imaging Systems, Inc.
Radiology · 183d
Cleared Jun 29, 1993
CVIS INSIGHT IMAGING CATHETER
K924922
Cardiovascular Imaging Systems, Inc.
Radiology · 330d