K-number	K223177
Device name	Highlander 014 PTA Balloon Dilatation Catheter
Applicant	C.R. Bard, Inc.
Product code	LIT
Device class	Class II
Decision date	Jan 20, 2023
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Highlander 014 PTA Balloon Dilatation Catheter

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Highlander 014 PTA Balloon Dilatation Catheter