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
49–72 of 99
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 May 18, 1982
HEPARIN COATED THERMODILUTION CATHETER
K821235
Gould, Inc.
Cardiovascular · 20d
Cleared Apr 29, 1982
SEPTISLEEVE
K820883
Argon Medical Corp.
Cardiovascular · 30d
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
Cleared Feb 04, 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
K810124
American Edwards Laboratories
Cardiovascular · 16d
Cleared Nov 20, 1980
SWAN GANZ CATHETER PLACEMENT KIT
K802288
Stanco Medical, Inc.
Cardiovascular · 62d
Cleared Oct 10, 1980
TORQUE CONTROL BALLOON CATHETER
K802338
Cordis Corp.
Cardiovascular · 14d
Cleared Aug 20, 1980
CORDIS FLOW DIRECTED BALLOON CATHETER
K801865
Cordis Corp.
Cardiovascular · 15d
Cleared Dec 15, 1978
CATHETER, USCI GRUNTZIG/BALLOON
K782071
C.R. Bard, Inc.
Cardiovascular · 2d
Cleared Nov 15, 1977
CATHETER, PACING/MONITORING
K772059
Electro-Catheter Corp.
Cardiovascular · 15d
Cleared Mar 30, 1977
CATHETER, GRUNTZIG, BALLON
K770522
Cook, Inc.
Cardiovascular · 12d
Cleared Sep 09, 1976
CATHETER, FLOW DIRECTED THERMAL DILUTION
K760533
Gould, Inc.
Cardiovascular · 10d