K-number	K172571
Device name	ULTRASCORE Focused Force PTA Balloon
Applicant	C. R. Bard
Product code	PNO
Device class	Class II
Decision date	Sep 22, 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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