Class Class II

VitaSmart Hypothermic Oxygenated Perfusion System (DEN250009)

DEN250009 2026-01-15 Direct
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Description

VitaSmart Hypothermic Oxygenated Perfusion System by Bridge TO Life, Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN250009
Clearance Date2026-01-15
Clearance TypeDirect
Product CodeSGY
Regulation Number876.5881

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