K-number	K192399
Device name	Infinity Angioplasty Balloon Catheter
Applicant	Infinity Angioplasty Balloon Company, LLC
Product code	LIT
Device class	Class II
Decision date	May 20, 2020
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Infinity Angioplasty Balloon Catheter

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