K-number	K223905
Device name	Vivio® LVEDP System
Applicant	Avicena, LLC
Product code	QUO
Device class	Class II
Decision date	Oct 6, 2023
Decision	Substantially Equivalent
Regulation	870.2200

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Source

View the full FDA submission: accessdata.fda.gov

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Vivio® LVEDP System

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