K-number	K130430
Device name	IVAS 10MM AND 15MM BALLOON CATHETER
Applicant	Stryker Corporation
Product code	HRX
Device class	Class II
Decision date	May 23, 2013
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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IVAS 10MM AND 15MM BALLOON CATHETER

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