VitaSmart Hypothermic Oxygenated Perfusion System— 510(k) DEN250009

Name: FDA 510(k) clearance DEN250009
Creator: U.S. Food and Drug Administration
Published: 2026-01-15

Unknown

Bridge TO Life, Ltd.

FDA 510(k) clearance DEN250009 for VitaSmart Hypothermic Oxygenated Perfusion System, Unknown on 2026-01-15. Applicant: Bridge TO Life, Ltd.. Device class: 2.

Clearance details

Applicant: Bridge TO Life, Ltd.
Product code: Code SGY
Device class: Class 2
Regulation: 21 CFR 876.5881
Advisory panel: Gastroenterology, Urology
Date received: 2025-03-31
Decision date: 2026-01-15
Decision: Unknown
Clearance type: Direct
Location: Northbrook, IL, US

View on FDA.gov ↗

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