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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 Number
870.1252
Classification Product Code
PQK
Date Received
01/10/2017
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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