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510(k) K121083

TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA by Loma Vista Medical — Product Code OZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2012
Date Received
April 10, 2012
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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