K-number	K163420
Device name	UltraScore Focused Force PTA Balloon
Applicant	Bard Peripheral Vascular, Inc.
Product code	PNO
Device class	Class II
Decision date	Jun 14, 2017
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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UltraScore Focused Force PTA Balloon

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