OMZ
5 FDA 510(k) clearances · Product code
83 daysmedian time to decision
101 days90th percentile
5clearances measured
FDA profile
- Official device name
- Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Medical specialty
- Cardiovascular
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Edwards Balloon Catheter (K153069) | Edwards Lifesciences | 2016-01-07 |
| VIDA PTV DILATATON CATHETER (K131002) | C.R. Bard, Inc. | 2013-07-02 |
| BARD PTV DILATATION CATHETER (K122367) | C.R. Bard, Inc. | 2012-11-02 |
| MULLINS-X PTV CATHETER (K102473) | NuMED, Inc. | 2010-12-09 |
| NUMED COEFFICIENT PTV CATHETERS (K014124) | NuMED, Inc. | 2002-01-16 |
Track OMZ automatically
Every clearance here is in the API, with alerts when new ones post.