510(k) DEN250009

VitaSmart Hypothermic Oxygenated Perfusion System by Bridge TO Life, Ltd. — Product Code SGY

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: January 15, 2026
Date Received: March 31, 2025
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Device Class: Class II
Regulation Number: 876.5881
Review Panel: GU
Submission Type

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.

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