K-number	K072800
Device name	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
Applicant	Cardiovascular Systems, Inc.
Product code	MCW
Device class	Class II
Decision date	Oct 25, 2007
Decision	Substantially Equivalent
Regulation	870.4875

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View the full FDA submission: accessdata.fda.gov

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DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

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