K-number	K191275
Device name	AllInCath 035M PTA Balloon Dilatation Catheter
Applicant	Nexstep Medical
Product code	LIT
Device class	Class II
Decision date	Jan 15, 2020
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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AllInCath 035M PTA Balloon Dilatation Catheter

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AllInCath 035M PTA Balloon Dilatation Catheter