K-number	DEN160006
Device name	everlinQ endoAVF System
Applicant	Tva Medical, Inc.
Product code	PQK
Device class	Class II
Decision date	Jun 22, 2018
Decision	Not Substantially Equivalent
Regulation	870.1252

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Source

View the full FDA submission: accessdata.fda.gov

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everlinQ endoAVF System

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