K-number	K141801
Device name	HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
Applicant	Covidien, LLC
Product code	MCW
Device class	Class II
Decision date	Oct 16, 2014
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM

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