K-number	K100819
Device name	THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
Applicant	Onset Medical Corporation
Product code	DYB
Device class	Class II
Decision date	Aug 2, 2010
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

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