K-number	K113681
Device name	GLADIATOR PTA BALLOON DILATION CATHETER
Applicant	Boston Scientific
Product code	LIT
Device class	Class II
Decision date	Jan 11, 2012
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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GLADIATOR PTA BALLOON DILATION CATHETER

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