K-number	K212351
Device name	Revolution Peripheral Atherectomy System
Applicant	Rex Medical, L.P.
Product code	MCW
Device class	Class II
Decision date	Dec 15, 2021
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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Revolution Peripheral Atherectomy System

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