K-number	K133999
Device name	DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Applicant	Cardiovascular Systems, Inc.
Product code	MCW
Device class	Class II
Decision date	Feb 28, 2014
Decision	Substantially Equivalent
Regulation	870.4875

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View the full FDA submission: accessdata.fda.gov

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DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

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