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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 brain intraparenchymal infusion cannula
De Novo Number DEN240023
Device Name SmartFlow Neuro Cannula
Requester
clearpoint neuro, inc.
120 s. sierra ave., suite 100
solana beach,  CA  92075
Contact brennan sullivan
Regulation Number882.4110
Classification Product Code
SDG  
Date Received05/22/2024
Decision Date 11/13/2024
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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