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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 creation of an arteriovenous fistula for hemodialysis access
De Novo Number DEN170004
Device Name Ellipsys Vascular Access System
Requester
avenu medical, inc
27123 calle arroyo, suite 2101
san juan capistrano,  CA  92675
Contact rebecca k. pine
Regulation Number870.1252
Classification Product Code
PQK  
Date Received01/10/2017
Decision Date 06/22/2018
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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