K-number	K241478
Device name	Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Applicant	Brosmed Medical Co., Ltd.
Product code	PNO
Device class	Class II
Decision date	Oct 22, 2024
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Tri-Wedge PTA Scoring Balloon Dilatation Catheter

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