K-number	K203390
Device name	Artimes pro Balloon Dilatation Catheter
Applicant	Brosmed Medical Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Apr 14, 2021
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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Artimes pro Balloon Dilatation Catheter

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