OMZ

Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

Product code: OMZ
Device name: Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Device class: Class 2
21 CFR: 21 CFR 870.1250
Medical specialty: Cardiovascular
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OMZ

Classification and pathway per current FDA publications. Data from openFDA (CC0).