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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hypothermic machine perfusion system and accessories for orthotopic liver transplant
Definition A hypothermic machine perfusion system and accessories for orthotopic liver transplant is a device that performs oxygenated perfusion of liver grafts at sub-physiological temperatures until it is transplanted into a recipient patient. This generic type of device may also include perfusion sets, oxygenators, and other components of the perfusion circuit.
Product CodeSGY
Regulation Number 876.5881
Device Class 2


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ManufacturerDecision
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