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 Feb 23, 1996
BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS
K955485
B.Braun Medical, Inc.
Cardiovascular · 84d
Cleared Dec 01, 1995
ANGIOPTIC ANGIOGRAPHIC CATHETER
K954423
AngioDynamics, Inc.
Cardiovascular · 71d
Cleared Sep 12, 1995
EVOLUTION MICROCATHETER
K953114
Boston Scientific Corp
Cardiovascular · 71d
Cleared Aug 17, 1995
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882
B.Braun Medical, Inc.
Cardiovascular · 170d
Cleared Aug 08, 1995
TRANSIT-2 INFUSION CATHETER
K950910
Cordis Neurovascular, Inc.
Cardiovascular · 176d
Cleared Jun 22, 1995
SCIMED EXPO ANGIOGRAPHIC CATHETER
K951720
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Jun 13, 1995
0.035 IN. WISE WIRE
K942927
Boston Scientific Corp
Radiology · 356d
Cleared May 16, 1995
TRANSIT-2 INFUSION CATHETER
K950909
Cordis Neurovascular, Inc.
Cardiovascular · 91d
Cleared Apr 05, 1995
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER
K950731
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared Mar 03, 1995
CONTROL
K944284
Daig Corp.
Cardiovascular · 182d
Cleared Dec 21, 1994
DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION
K935985
Deroyal Industries, Inc.
Cardiovascular · 372d
Cleared Dec 13, 1994
HIGH PRESSURE TUBING
K941978
Abbott Laboratories
Cardiovascular · 243d
Cleared Nov 22, 1994
SCIMED CHOICE(TM) PTCA GUIDE WIRE
K943192
Scimed Life Systems, Inc.
Cardiovascular · 140d
Cleared Nov 15, 1994
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K943739
Mallinckrodt Medical
Cardiovascular · 105d
Cleared Sep 22, 1994
CARDIAC CATHETERIZATION KIT
K932141
Abbott Laboratories
Cardiovascular · 518d
Cleared Aug 31, 1994
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM
K942939
Cordis Corp.
Cardiovascular · 70d
Cleared Jul 18, 1994
TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
K936282
Cordis Neurovascular, Inc.
Cardiovascular · 200d
Cleared Jun 20, 1994
HAND CONTROLLED SYRINGE
K942329
Abbott Laboratories
Cardiovascular · 35d
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 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