DYG · Class II · 21 CFR 870.1240

FDA Product Code DYG: Catheter, Flow Directed

Leading manufacturers include Baxter Healthcare Corp, American Edwards Laboratories and Medtronic Vascular.

99
Total
99
Cleared
107d
Avg days
1976
Since
99 devices
25–48 of 99
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 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 Aug 29, 1986
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
K862119
Parke-Davis Co.
Cardiovascular · 87d
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 Jun 11, 1984
DESERET HEPARIN COATED FLOW CATH
K841251
Parke-Davis Co.
Cardiovascular · 77d
Cleared Jun 11, 1984
DESERET HEPARIN COATED FLOW DIRECTED
K841317
Parke-Davis Co.
Cardiovascular · 70d
Cleared Feb 04, 1984
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836
Instrumentation Laboratory CO
Cardiovascular · 81d
Cleared Jan 30, 1984
HEPARIN-COATED BALLOON THERMODILUT
K833572
Critikon Company, LLC
Cardiovascular · 110d
Cleared Jan 30, 1984
INFUSION PORT BALLOON THERMODILUTION
K833918
Critikon Company, LLC
Cardiovascular · 77d
Cleared Nov 28, 1983
PROTECTIVE SLEEVE
K832380
Vertex Medical Corp.
Cardiovascular · 132d
Cleared Oct 20, 1983
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854
C.R. Bard, Inc.
Cardiovascular · 133d
Cleared Sep 29, 1983
FLOW-DIRECTED HEPARIN COATED THERMODIL
K832957
Sorensen Research
Cardiovascular · 29d
Cleared Aug 12, 1983
ELECATH BALTHERM TLC THERMAL DILUTION
K831945
Electro-Catheter Corp.
Cardiovascular · 57d
Cleared May 27, 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185
Cook, Inc.
Cardiovascular · 45d