K-number	K132728
Device name	V8 TRANSLUMINAL BAV CATHETER
Applicant	Intervalve, Inc.
Product code	OZT
Device class	Class II
Decision date	Nov 22, 2013
Decision	Substantially Equivalent
Regulation	870.1255

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Source

View the full FDA submission: accessdata.fda.gov

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V8 TRANSLUMINAL BAV CATHETER

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