Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5881
Review panel
GU
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.