K-number	K132810
Device name	GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
Applicant	Boston Scientific Corp
Product code	LIT
Device class	Class II
Decision date	Feb 28, 2014
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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GLADIATOR ELITE PTA BALLOON DILATATION CATHETER

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