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
193–216 of 501
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
Cleared Mar 29, 1996
SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)
K960801
North American Instrument Corp.
Cardiovascular · 31d
Cleared Feb 23, 1996
BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS
K955485
B.Braun Medical, Inc.
Cardiovascular · 84d
Cleared Jan 31, 1996
MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER
K955111
Adam Spence Corp.
Cardiovascular · 84d
Cleared Jan 29, 1996
MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)
K952984
Map Medical Equipment, Inc.
Cardiovascular · 215d
Cleared Dec 01, 1995
ANGIOPTIC ANGIOGRAPHIC CATHETER
K954423
AngioDynamics, Inc.
Cardiovascular · 71d
Cleared Nov 07, 1995
MIKRO-TIP ANGIOGRAPHIC CATHETER
K952773
Millar Instruments, Inc.
Cardiovascular · 144d
Cleared Oct 05, 1995
CATHETER, BALLOON TYPE
K950398
Interventional Therapeutics Corp.
Cardiovascular · 246d
Cleared Sep 15, 1995
DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K950440
J-Lloyd Medical, Inc.
Cardiovascular · 231d
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