SGY · Class II · 21 CFR 876.5881

FDA Product Code 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.

Leading manufacturers include Bridge TO Life, Ltd..

1
Total
0
Cleared
290d
Avg days
2026
Since

FDA 510(k) Cleared Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant Devices (Product Code SGY)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant devices (product code SGY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →