K-number	K152150
Device name	V8 Balloon Aortic Valvuloplasty Catheter
Applicant	Intervalve, Inc.
Product code	OZT
Device class	Class II
Decision date	Dec 18, 2015
Decision	Substantially Equivalent
Regulation	870.1255

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View the full FDA submission: accessdata.fda.gov

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V8 Balloon Aortic Valvuloplasty Catheter

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