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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 temporary embolization assist device, peripheral
De Novo Number DEN230064
Device Name BraidE Embolization Assist Device
Requester
rapid medical ltd.
carmel building, pob 337
yokneam,  IL 2069205
Contact ina gutman
Regulation Number870.3325
Classification Product Code
QZU  
Date Received09/19/2023
Decision Date 02/21/2024
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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