# OMZ: Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 1
- 2010: 1
- 2012: 1
- 2013: 1
- 2016: 1

## Most-cited predicates
- K131002: Vida PTV Dilataton Catheter (2013), cited by 2
- K102473: Mullins-X PTV Catheter (2010), cited by 1
- K014124: Numed Coefficient PTV Catheters (2002), cited by 1
- K122367: Bard PTV Dilatation Catheter (2012), cited by 1

Source page: https://510kreport.com/product-code/OMZ
Data by year (CSV): https://510kreport.com/product-code/OMZ.csv