TPLC - Total Product Life Cycle

Device	catheter and tip, suction
Regulation Description	Vacuum-powered body fluid suction apparatus.
Product Code	JOL
Regulation Number	880.6740
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
APLICARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT WITH DRUG	1
AXIOM
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	4
BEMIS HEALTH CARE
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPACT INSTRUMENTATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	4
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
1. K943773 STERILE WATER
MEGADYNE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
PFIZER
	SUBSTANTIALLY EQUIVALENT	1
PRIMARY CARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SUPERIOR HEALTHCARE GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRINITY
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
VITAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELCON, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Break	14
Detachment of device component	11
Fluid leak	6
No Known Device Problem	6
Leak	4
User used incorrect product for intended use	3
Tip breakage	3
Material fragmentation	3
Component(s), broken	3
Unknown (for use when the device problem is not known)	2
Aspiration issue	1
Other (for use when an appropriate device code cannot be identified)	1
Total Device Problems	57

Recalls
Manufacturer		Recall Class	Date Posted
1	Invuity, Inc.	II	Oct-03-2012