K-number	K163701
Device name	Direxion and Direxion HI-FLO Torqueable Microcatheters
Applicant	Boston Scientific Corporation
Product code	KRA
Device class	Class II
Decision date	May 16, 2017
Decision	Substantially Equivalent
Regulation	870.1210

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View the full FDA submission: accessdata.fda.gov

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Direxion and Direxion HI-FLO Torqueable Microcatheters

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