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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 percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures
De Novo Number DEN240017
Device Name ShortCut
Requester
pi-cardia ltd.
5 david fikes st.
rehovot,  IL 7632805
Contact hadas givon
Regulation Number870.1254
Classification Product Code
SCZ  
Date Received04/17/2024
Decision Date 09/27/2024
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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