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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 extravascular support for an arteriovenous fistula for vascular access
De Novo Number DEN220026
Device Name VasQ
Requester
laminate medical technologies ltd.
24 raoul wallenberg st.
tel aviv,  IL 6971921
Contact orit yarden
Regulation Number870.4600
Classification Product Code
QVQ  
Date Received04/29/2022
Decision Date 09/26/2023
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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