K-number	K211738
Device name	Rotarex Atherectomy System
Applicant	C.R. Bard, Inc.
Product code	MCW
Device class	Class II
Decision date	Sep 14, 2021
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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Rotarex Atherectomy System

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