Name: Predicase
Price: 199 USD

K-number	DEN250009
Device name	VitaSmart Hypothermic Oxygenated Perfusion System
Applicant	Bridge TO Life, Ltd.
Product code	SGY
Device class	Class II
Decision date	Jan 15, 2026
Decision	Not Substantially Equivalent
Regulation	876.5881

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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VitaSmart Hypothermic Oxygenated Perfusion System

Everything you need for a 510(k) submission. Nothing you don't.