K-number	K142199
Device name	Ascendra Balloon Aortic Valvaloplasty Catheter
Applicant	Edwards Lifesciences
Product code	OZT
Device class	Class II
Decision date	Oct 29, 2014
Decision	Substantially Equivalent
Regulation	870.1255

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Source

View the full FDA submission: accessdata.fda.gov

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Ascendra Balloon Aortic Valvaloplasty Catheter

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