K-number	K221077
Device name	Auryon Atherectomy System
Applicant	Eximo Medical, Ltd.
Product code	MCW
Device class	Class II
Decision date	Jun 9, 2022
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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Auryon Atherectomy System

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