DYG · Class II · 21 CFR 870.1240

FDA Product Code DYG: Catheter, Flow Directed

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

99
Total
99
Cleared
107d
Avg days
1976
Since
99 devices
49–72 of 99
Cleared Jul 13, 1984
WEDGE PRESSURE CATHETER FLOW DIRECTED
K841705
Mansfield Scientific, Inc.
Cardiovascular · 81d
Cleared Jul 13, 1984
POLYURETHANE THERMAL DILUTION CATHET
K841876
Waters Instruments, Inc.
Cardiovascular · 67d
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 Jan 10, 1984
HEPARIN COATED BALLOON THERMODILU
K834036
Nova Medical Specialties
Cardiovascular · 48d
Cleared Jan 10, 1984
HEPARIN COATED BALLOON THERMODILU
K834037
Nova Medical Specialties
Cardiovascular · 48d
Cleared Nov 28, 1983
PROTECTIVE SLEEVE
K832380
Vertex Medical Corp.
Cardiovascular · 132d
Cleared Nov 03, 1983
THERMAL DILUTION CATHETER
K832324
Catheter Corp. of America
Cardiovascular · 111d
Cleared Oct 20, 1983
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854
C.R. Bard, Inc.
Cardiovascular · 133d
Cleared Oct 19, 1983
NOVA BALLOON THERMODILUTION INFUSION
K832287
Nova Medical Specialties
Cardiovascular · 98d
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 Jul 18, 1983
WEDGE PRESSURE CATHETER
K830604
Plasmedics, Inc.
Cardiovascular · 143d
Cleared May 27, 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185
Cook, Inc.
Cardiovascular · 45d
Cleared Dec 22, 1982
THERMAL DILUTION CATHETER
K823484
Instrumentation Laboratory CO
Cardiovascular · 29d
Cleared Nov 30, 1982
BALLOON THERMODILUTION CATHETER #7164&
K823433
Critikon Company, LLC
Cardiovascular · 14d
Cleared Nov 01, 1982
BALLOON WEDGE PRESSURE, ANGIOGRAPHIC
K822806
Nova Medical Specialties
Cardiovascular · 45d
Cleared Nov 01, 1982
OPTICATH HEPARIN COATED, FLOW-DIRECT
K823007
Oximetrix, Inc.
Cardiovascular · 20d
Cleared Oct 15, 1982
SWAN-GANZ BIPOLAR PACING CATHETER
K822723
American Edwards Laboratories
Cardiovascular · 38d
Cleared Aug 24, 1982
BALLOON WEDGE PRESSURE CATHETER
K822034
Ziehm International, Inc.
Cardiovascular · 43d
Cleared Aug 24, 1982
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
K822350
American Edwards Laboratories
Cardiovascular · 18d