K-number	K171665
Device name	Microcatheter and guide-wire system
Applicant	Suzhou Hengrui Disheng Medical Co., Ltd.
Product code	KRA
Device class	Class II
Decision date	Jan 11, 2018
Decision	Substantially Equivalent
Regulation	870.1210

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View the full FDA submission: accessdata.fda.gov

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Microcatheter and guide-wire system

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