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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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