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OMZ — Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter Class II

FDA Device Classification

Classification Details

Product Code
OMZ
Device Class
Class II
Regulation Number
870.1250
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K153069edwards lifesciencesEdwards Balloon CatheterJanuary 7, 2016
K131002c.r. bardVIDA PTV DILATATON CATHETERJuly 2, 2013
K122367c.r. bardBARD PTV DILATATION CATHETERNovember 2, 2012
K102473numedMULLINS-X PTV CATHETERDecember 9, 2010
K014124numedNUMED COEFFICIENT PTV CATHETERSJanuary 16, 2002