K-number	K210660
Device name	Stone Retrieval Balloon Catheter
Applicant	Anrei Medical (Hangzhou) Co., Ltd.
Product code	GCA
Device class	Class II
Decision date	Apr 27, 2021
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Stone Retrieval Balloon Catheter

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