DYG · Class II · 21 CFR 870.1240

FDA Product Code DYG: Catheter, Flow Directed

Leading manufacturers include Baxter Healthcare Corp, American Edwards Laboratories and C.R. Bard, Inc..

99
Total
99
Cleared
107d
Avg days
1976
Since
99 devices
25–48 of 99
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 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 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
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 Oct 15, 1982
SWAN-GANZ BIPOLAR PACING CATHETER
K822723
American Edwards Laboratories
Cardiovascular · 38d
Cleared Aug 24, 1982
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
K822350
American Edwards Laboratories
Cardiovascular · 18d
Cleared Jul 30, 1982
LEONARD PERIPHERAL VENOUS PRESSURE CATH
K821996
Norton Performance Plastics Corp.
Cardiovascular · 23d
Cleared May 25, 1982
MEDTRONIC S3 TM SYSTEM
K821004
Medtronic Vascular
Cardiovascular · 46d
Cleared Apr 21, 1982
IL 7F FLOW DIRECTOR THERMAL DILU. CATH
K820702
Instrumentation Laboratory CO
Cardiovascular · 37d
Cleared Feb 12, 1982
SWAN-GANZ VIP-CATHETER
K820222
American Edwards Laboratories
Cardiovascular · 16d
Cleared Feb 12, 1982
NORTON FLOW DIRECTED THERMODILUTION CATH
K820229
Norton Performance Plastics Corp.
Cardiovascular · 16d
Cleared Sep 25, 1981
FLOW-DIRECTED THERMODILUTION CATHETER
K812324
Sorensen Research
Cardiovascular · 39d
Cleared Sep 25, 1981
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
K812563
American Edwards Laboratories
Cardiovascular · 17d
Cleared Mar 27, 1981
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
K810352
American Edwards Laboratories
Cardiovascular · 45d