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510(k) K152613

True Flow Valvuloplasty Perfusion Catheter by C.R. Bard, Inc. — Product Code OZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2016
Date Received
September 14, 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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Other clearances for product code OZT

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  • K150343 — V8 Transluminal BAV Catheter (April 3, 2015)
  • K142199 — Ascendra Balloon Aortic Valvaloplasty Catheter (October 29, 2014)