LDR · Class II · 21 CFR 880.5725

FDA Product Code LDR: Controller, Infusion, Intravascular, Electronic

Leading manufacturers include Y, Travenol Laboratories, S.A. and Abbott Laboratories.

60
Total
60
Cleared
83d
Avg days
1976
Since
60 devices
25–48 of 60
Cleared Jan 25, 1984
FLO-GARD 8000 COMPUTER CONTROL INFUSI
K834154
Travenol Laboratories, S.A.
General Hospital · 54d
Cleared Apr 08, 1983
KOALA C99 I.V. CONTROLLER
K830780
Chesebrough-Pond'S U.S.A. Co.
General Hospital · 28d
Cleared Dec 22, 1982
VOLUMERIC CONTROLLER
K823404
Quest Medical, Inc.
General Hospital · 37d
Cleared Nov 22, 1982
380 PIGGYBACK CONTROLLER
K823026
Imed Corp.
General Hospital · 39d
Cleared Jul 21, 1982
SKIN SCRUB-TRAY
K821579
Associated Medical Products Co.
General Hospital · 54d
Cleared Sep 16, 1981
TRAVENOL INFUSION CONTROLLER 2M8052
K812510
Travenol Laboratories, S.A.
General Hospital · 14d
Cleared Aug 20, 1981
LIFECARE 1000 CONTROLLER
K812114
Abbott Laboratories
General Hospital · 24d
Cleared Jul 13, 1981
MILLIPORE DUAL RATE INTRAVENOUS CASSETTE
K811432
Millipore Corp.
General Hospital · 52d
Cleared Aug 27, 1980
IVAC 260 SERIES VOLUME TRIC INFUSION CON
K801861
Y
General Hospital · 22d