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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name hypothermic machine perfusion system and accessories for orthotopic liver transplant
De Novo Number DEN250009
Device Name VitaSmart Hypothermic Oxygenated Perfusion System
Requester
bridge to life, ltd.
707 skokie blvd., suite 340
northbrook,  IL  60062
Contact stephen howerton
Regulation Number876.5881
Classification Product Code
SGY  
Date Received03/31/2025
Decision Date 01/15/2026
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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