TPLC - Total Product Life Cycle

Device	set, i.v. fluid transfer
Regulation Description	Intravascular administration set.
Product Code	LHI
Regulation Number	880.5440
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	5
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALARIS MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	9
BAXA CORP.
	SUBSTANTIALLY EQUIVALENT	3
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	10
BD
	SUBSTANTIALLY EQUIVALENT	1
BERLEX
	SUBSTANTIALLY EQUIVALENT	1
BIOJECT, INC.
	SUBSTANTIALLY EQUIVALENT	2
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
1. K052790 SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
CARDIOMED
	SUBSTANTIALLY EQUIVALENT	1
CARMEL PHARMA, INC
	SUBSTANTIALLY EQUIVALENT	7
CODAN US CORP.
	SUBSTANTIALLY EQUIVALENT	1
EXELINT INTERNATIONAL CO.
	SUBSTANTIALLY EQUIVALENT	1
HALKEY-ROBERTS CORP.
	SUBSTANTIALLY EQUIVALENT	1
INRAD
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
METRIX CO.
	SUBSTANTIALLY EQUIVALENT	1
MIGADA PLANT
	SUBSTANTIALLY EQUIVALENT	2
NEXUS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
Q.I. MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
Remington Medical, Inc.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Leak	3
Device Difficult to Setup or Prepare	2
Break	2
Detachment of device component	2
Underdelivery	1
Total Device Problems	10