K-number	K212719
Device name	Micro Catheter and Guidewire System
Applicant	Suzhou Hengrui Hongyuan Medical Co., Ltd.
Product code	KRA
Device class	Class II
Decision date	Apr 11, 2022
Decision	Substantially Equivalent
Regulation	870.1210

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View the full FDA submission: accessdata.fda.gov

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Micro Catheter and Guidewire System

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