SGYClass IILife-sustaining
Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Gastroenterology, Urology · 21 CFR 876.5881
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.
MDR events0All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
0 adverse event reports on file
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Event type breakdown
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code