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510(k) K150667

True Dilatation Balloon Valvuloplasty Catheter by C.R. Bard, Inc. — Product Code OZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2015
Date Received
March 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon Aortic Valvuloplasty
Device Class
Class II
Regulation Number
870.1255
Review Panel
CV
Submission Type

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.

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