K-number	K181877
Device name	Phoenix 2.4mm Atherectomy Plus System
Applicant	Volcano Atheromed, Inc.
Product code	MCW
Device class	Class II
Decision date	Dec 17, 2018
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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Phoenix 2.4mm Atherectomy Plus System

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