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
73–96 of 99
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
FLOW DIRECTED THERMAL-DILUTION INFUSION
K821057
Oximetrix, Inc.
Cardiovascular · 32d
Cleared May 18, 1982
HEPARIN COATED THERMODILUTION CATHETER
K821099
Kma, Inc.
Cardiovascular · 28d
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 Jan 18, 1982
HEMOSTATIC SIDE-ARM ADAPTER
K813578
Advanced Catheter Systems
Cardiovascular · 26d
Cleared Nov 16, 1981
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH
K812111
Bionomy, Inc.
Cardiovascular · 112d
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 Jun 30, 1981
OCCLUSION CATHETER
K811276
Bionomy, Inc.
Cardiovascular · 53d
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 Dec 20, 1977
SWAN GANZ
K771043
Clincal Instruments Corp.
Cardiovascular · 194d
Cleared Dec 20, 1977
CATHETER, CARDIOVASCULAR
K771823
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Nov 15, 1977
CATHETER, PACING/MONITORING
K772059
Electro-Catheter Corp.
Cardiovascular · 15d
Cleared Sep 14, 1977
THERMOCATH
K771306
Victory Engineering Corp.
Cardiovascular · 62d