OMZ — Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter Class II
FDA product code OMZ covers "Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter", a Class II medical device regulated under 21 CFR 870.1250. Submissions are reviewed by the Cardiovascular panel. At least 5 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K153069 | edwards lifesciences | Edwards Balloon Catheter | January 7, 2016 |
| K131002 | c.r. bard | VIDA PTV DILATATON CATHETER | July 2, 2013 |
| K122367 | c.r. bard | BARD PTV DILATATION CATHETER | November 2, 2012 |
| K102473 | numed | MULLINS-X PTV CATHETER | December 9, 2010 |
| K014124 | numed | NUMED COEFFICIENT PTV CATHETERS | January 16, 2002 |