K-number	K213578
Device name	Balloon Dilatation Catheter
Applicant	Hangzhou AGS MedTech Co., Ltd.
Product code	FDF
Device class	Class II
Decision date	Apr 6, 2022
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Balloon Dilatation Catheter

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