OMZClass II

Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

21 CFR 870.1250 / Cardiovascular

OMZ is the FDA product code for Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter, a class II device type, regulated under 21 CFR 870.1250. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2016-01-07, and no recalls.

Classification record

Product code: OMZ
Device name: Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
FDA 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.
Regulation: 21 CFR 870.1250
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 0

Clearances, product code OMZ

By decision year

5 clearances under product code OMZ with a decision year between 2002 and 2016, 2002 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OMZ by decision year
Year	Clearances
2002	1
2010	1
2012	1
2013	1
2016	1

Applicants with the most clearances

Product code OMZ

Applicants holding the most 510(k) clearances under product code OMZ
Applicant	Clearances
C.R. Bard Inc	2
Numed Inc	2
Edwards Lifesciences LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OMZ

Recent recalls

Product code OMZ

FDA records show no recalls under product code OMZ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)