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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 predictive indicator for long-term cardiovascular outcomes
De Novo Number DEN250042
Device Name CaRi-Heart
Requester
caristo diagnostics , ltd.
263 tresser blvd., 9th floor
one stamford plz.
stamford,  CT  06901
Contact frank cheng
Regulation Number870.2215
Classification Product Code
SIU  
Date Received09/04/2025
Decision Date 07/28/2026
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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