K-number	K201246
Device name	PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)
Applicant	Qualimed USA, LLC
Product code	LIT
Device class	Class II
Decision date	Aug 3, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)

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