MEA · Class II · 21 CFR 880.5725

FDA Product Code MEA: Pump, Infusion, Pca

Leading manufacturers include Baxter Healthcare Corp, Hospira, Inc. and Pharmacia Deltec, Inc..

31
Total
31
Cleared
162d
Avg days
1991
Since
31 devices
25–31 of 31
Cleared Jan 15, 1993
PRIME PCA AND PCA/CONTINUOUS SYSTEMS
K920637
Prime Medical Products, Inc.
General Hospital · 338d
Cleared Aug 24, 1992
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
K915270
Graseby Medical , Ltd.
General Hospital · 273d
Cleared Aug 03, 1992
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K921994
C.R. Bard, Inc.
General Hospital · 97d
Cleared Jun 03, 1992
IVAC PC ANIFUSER
K915063
Y
General Hospital · 208d
Cleared Dec 18, 1991
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K914502
C.R. Bard, Inc.
General Hospital · 70d
Cleared Nov 07, 1991
BAXA PCA INFUSOR
K910257
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 289d
Cleared Jun 11, 1991
CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP
K911791
Pharmacia Deltec, Inc.
General Hospital · 50d