FDA PRODUCT CODE · CLASS II
SGY — Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
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.
Recent clearances
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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