DYG · Class II · 21 CFR 870.1240

FDA Product Code DYG: Catheter, Flow Directed

Leading manufacturers include Nova Medical Specialties, Baxter Healthcare Corp and American Edwards Laboratories.

99
Total
99
Cleared
107d
Avg days
1976
Since
99 devices
25–48 of 99
Cleared Jul 19, 1993
CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR
K925444
Ami-Med Corp.
Cardiovascular · 264d
Cleared Jan 13, 1993
FLOW DIRECTED THERMODILUTION BALLOON CATHETER
K920869
J-Lloyd Medical, Inc.
Cardiovascular · 323d
Cleared Jun 03, 1991
INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER
K911840
Intec Medical, Inc.
Cardiovascular · 39d
Cleared Feb 20, 1991
INTHERM TEMPORARY OCCLUSION CATHETER
K901287
Interventional Therapeutics Corp.
Cardiovascular · 337d
Cleared Jan 16, 1991
STEALTH DILATION CATHETER SYSTEM/MODIFICATION
K904287
Target Therapeutics
Cardiovascular · 124d
Cleared Jul 31, 1990
TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
K901247
Intec Medical, Inc.
Cardiovascular · 138d
Cleared May 10, 1990
SOFT-WEDGE(TM) SYRINGE
K900879
Baxter Healthcare Corp
Cardiovascular · 73d
Cleared Feb 08, 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466
Baxter Healthcare Corp
Cardiovascular · 87d
Cleared Sep 26, 1989
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
K892530
Arrow Intl., Inc.
Cardiovascular · 168d
Cleared Sep 26, 1989
SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
K893435
Cathlab Corp.
Cardiovascular · 147d
Cleared Sep 05, 1989
BARD CATH LAB THERMODILUTION CATHETER
K893474
C.R. Bard, Inc.
Cardiovascular · 124d
Cleared Apr 21, 1989
MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
K883948
NuMED, Inc.
Cardiovascular · 220d
Cleared May 25, 1988
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465
Abbott Laboratories
Cardiovascular · 208d
Cleared Nov 05, 1987
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117
Medtronic Vascular
Cardiovascular · 27d
Cleared Oct 15, 1987
DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.
K872770
Nova Medical Specialties
Cardiovascular · 93d
Cleared Aug 29, 1986
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
K862119
Parke-Davis Co.
Cardiovascular · 87d
Cleared Dec 03, 1985
CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
K853383
Webster Laboratories, Inc.
Cardiovascular · 113d
Cleared Sep 17, 1985
BARD-PARKER OCCLUSION BALLOON CATHETER
K852294
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 111d
Cleared Aug 05, 1985
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
K850952
C.R. Bard, Inc.
Cardiovascular · 151d
Cleared Jun 20, 1985
MEDTRONIC MODEL 6404
K851948
Medtronic Vascular
Cardiovascular · 48d
Cleared Oct 18, 1984
FLOW-DIRECTED THERMODILUTION CATH
K843409
Andover Medical, Inc.
Cardiovascular · 48d
Cleared Oct 18, 1984
THERMAL DILUTION CATHETER
K843411
Andover Medical, Inc.
Cardiovascular · 48d
Cleared Aug 12, 1984
NOVA BALLOON THERMODILUTION CATH.
K841639
Nova Medical Specialties
Cardiovascular · 114d
Cleared Aug 12, 1984
NOVA BALLOON THERMODILUTION INFUSION
K841640
Nova Medical Specialties
Cardiovascular · 114d