K-number	K213728
Device name	Serranator PTA Serration Balloon Catheter
Applicant	Cagent Vascular, LLC
Product code	PNO
Device class	Class II
Decision date	Dec 15, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Serranator PTA Serration Balloon Catheter

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