MEB · Class II · 21 CFR 880.5725

FDA Product Code MEB: Pump, Infusion, Elastomeric

Leading manufacturers include I-Flow Corp., Baxter Healthcare Corp and Novacon Corp..

88
Total
88
Cleared
118d
Avg days
1992
Since
88 devices
73–88 of 88
Cleared Aug 05, 1996
DIB INFUSOR
K955849
Novacon Corp.
General Hospital · 222d
Cleared Aug 05, 1996
DIB INFUSOR-RA
K960318
Novacon Corp.
General Hospital · 195d
Cleared Feb 08, 1996
BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET
K955727
I-Flow Corp.
General Hospital · 52d
Cleared Sep 29, 1995
TITAN 20 CC DRIVER
K954059
I-Flow Corp.
General Hospital · 31d
Cleared Sep 28, 1995
TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET
K953028
I-Flow Corp.
General Hospital · 91d
Cleared Jul 18, 1995
INFUSION PUMP
K941418
I-Flow Corp.
General Hospital · 482d
Cleared Feb 14, 1995
DIB INFUSORS
K944665
Novacon Corp.
General Hospital · 155d
Cleared Nov 03, 1994
INTERMATE XLV ELASTOMERIC INFUSION SYSTEM
K943664
Baxter Healthcare Corp
General Hospital · 98d
Cleared Sep 02, 1994
DISPOSABLE, AMBULATORY, INFUSION PUMPS
K940406
Vlv Associates, Inc.
General Hospital · 218d
Cleared Aug 05, 1994
DIB INFUSOR
K941766
Novacon Corp.
General Hospital · 116d
Cleared Jun 10, 1994
MID-500
K940117
Block Medical, Inc.
General Hospital · 151d
Cleared Feb 25, 1994
DIB INFUSOR
K930404
Novacon Corp.
General Hospital · 395d
Cleared Feb 05, 1993
INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
K922382
Baxter Healthcare Corp
General Hospital · 261d
Cleared Oct 05, 1992
PRIME CADI-120
K914148
Prime Medical Products, Inc.
General Hospital · 385d
Cleared Jul 17, 1992
GENESIS(TM) INFUSION SYSTEM
K911636
Norman'S
General Hospital · 463d
Cleared Mar 26, 1992
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
K913658
Imed Corp.
General Hospital · 241d