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510(k) K153069

Edwards Balloon Catheter by Edwards Lifesciences — Product Code OMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2016
Date Received
October 22, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

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Other clearances for product code OMZ

  • K131002 — VIDA PTV DILATATON CATHETER (July 2, 2013)
  • K122367 — BARD PTV DILATATION CATHETER (November 2, 2012)
  • K102473 — MULLINS-X PTV CATHETER (December 9, 2010)
  • K014124 — NUMED COEFFICIENT PTV CATHETERS (January 16, 2002)