Name: Predicase
Price: 199 USD

K-number	K041630
Device name	ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Applicant	Cardiovascular Systems Incorporated
Product code	MCW
Device class	Class II
Decision date	Jan 31, 2005
Decision	Substantially Equivalent
Regulation	870.4875

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View the full FDA submission: accessdata.fda.gov

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ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

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