Name: Predicase
Price: 199 USD

K-number	K111388
Device name	DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
Applicant	Cardiovascular Systems, Inc.
Product code	MCW
Device class	Class II
Decision date	Jul 26, 2011
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM

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