K-number	K150343
Device name	V8 Transluminal BAV Catheter
Applicant	Intervalve, Inc.
Product code	OZT
Device class	Class II
Decision date	Apr 3, 2015
Decision	Substantially Equivalent
Regulation	870.1255

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View the full FDA submission: accessdata.fda.gov

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V8 Transluminal BAV Catheter

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