TPLC - Total Product Life Cycle

Device	injector and syringe, angiographic
Regulation Description	Angiographic injector and syringe.
Product Code	DXT
Regulation Number	870.1650
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACCUMED SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ACIST MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	7
ADVANCED CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	4
ANGEION CORP.
	SUBSTANTIALLY EQUIVALENT	1
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
ATRION MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	4
COEUR MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	2
DEROYAL
	SUBSTANTIALLY EQUIVALENT - KIT	1
DOW
	SUBSTANTIALLY EQUIVALENT	1
E-Z-EM, INC.
	SUBSTANTIALLY EQUIVALENT	1
FLOWCARDIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
GISH BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MALLINCKRODT
	SUBSTANTIALLY EQUIVALENT	8
MEDICAL COMPONENTS
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MEDRAD, INC.
	SUBSTANTIALLY EQUIVALENT	32
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
	SUBSTANTIALLY EQUIVALENT	6
NAVILYST MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEMOTO KYORINDO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
OSPREY MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	10
SCIMED
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG WEIGAO MEDICAL POLYMER CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TOSHIBA
	SUBSTANTIALLY EQUIVALENT	1
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No Known Device Problem	23
Device operates differently than expected	21
Detachment of device component	15
Self-activation or keying	12
Component(s), broken	11
Air leak	11
Foreign material present in device	11
Device Issue	8
Dislodged or dislocated	7
Unknown (for use when the device problem is not known)	6
Break	5
Disconnection	5
Material integrity issue	5
Device displays error message	4
Use of Device Issue	3
Spillage, accidental	3
Component falling	3
Loose	3
Replace	3
Electrical shorting	2
Unintended system motion	2
Leak	2
Material separation	2
Inaccurate delivery	2
Spark	1
Connection issue	1
Malfunction	1
Failure to calibrate	1
Split	1
Defective item	1
Smoking	1
Noise	1
Other (for use when an appropriate device code cannot be identified)	1
Sticking	1
Inaccurate synchronization	1
System fails to activate	1
Tears, rips, holes in device, device material	1
Deflation issue	1
Overheating of device or device component	1
Program, failure to	1
Device remains activated	1
Fire	1
Inaccurate flowrate	1
Fluid leak	1
Foreign material	1
Inflation issue	1
Knotted	1
Bubble(s)	1
Burst	1
Escape	1
Infusion or flow issue	1
No Information	1
Total Device Problems	197