FDA product code OMZ: Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
OMZ is the FDA product code for pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 5 510(k) submissions under OMZ, from 3 different applicants. The average 510(k) review took 76 days (median 83).
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.
Classification
| Field | Value |
|---|---|
| Device name | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OMZ clearance
Top OMZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 2 | 2013-07-02 |
| NuMED, Inc. | 2 | 2010-12-09 |
| Edwards Lifesciences | 1 | 2016-01-07 |
Most recent OMZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153069 | Edwards Lifesciences | Edwards Balloon Catheter | 2016-01-07 | 77 |
| K131002 | C.R. Bard, Inc. | VIDA PTV DILATATON CATHETER | 2013-07-02 | 83 |
| K122367 | C.R. Bard, Inc. | BARD PTV DILATATION CATHETER | 2012-11-02 | 88 |
| K102473 | NuMED, Inc. | MULLINS-X PTV CATHETER | 2010-12-09 | 101 |
| K014124 | NuMED, Inc. | NUMED COEFFICIENT PTV CATHETERS | 2002-01-16 | 30 |
Recalls for OMZ devices
openFDA lists no recalls for product code OMZ.
Frequently asked questions
What is FDA product code OMZ?
OMZ is the FDA product code for pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is OMZ?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMZ?
Across 5 cleared submissions the average was 76 days from receipt to decision (median 83).
Which companies have the most OMZ clearances?
C.R. Bard, Inc. (2); NuMED, Inc. (2); Edwards Lifesciences (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMZ
- Run a recall and safety report across every OMZ manufacturer
- Watch product code OMZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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