K-number	K230263
Device name	Finesse Injectable PTA Balloon Dilatation Catheter
Applicant	Summa Therapeutics, LLC
Product code	LIT
Device class	Class II
Decision date	May 26, 2023
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Finesse Injectable PTA Balloon Dilatation Catheter

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Finesse Injectable PTA Balloon Dilatation Catheter