K-number	K083489
Device name	JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
Applicant	Pathway Medical Technologies, Inc.
Product code	MCW
Device class	Class II
Decision date	Jan 23, 2009
Decision	Substantially Equivalent
Regulation	870.4875

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View the full FDA submission: accessdata.fda.gov

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JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300

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