K-number	K092014
Device name	SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
Applicant	Onset Medical Corporation
Product code	DYB
Device class	Class II
Decision date	Oct 8, 2009
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

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