K-number	K212027
Device name	TurboHawk Plus Directional Atherectomy System
Applicant	Medtronic, Inc.
Product code	MCW
Device class	Class II
Decision date	Aug 24, 2021
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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TurboHawk Plus Directional Atherectomy System

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