# K153069: Edwards Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: Jan 7, 2016 after 77 days
- Product code: OMZ (Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931009 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040830: Pta, PTV, Atrioseptostomy, Angiographic, Sizing Catheters, NuMED, Inc. (2004) Summary page 4.

## Indications for use
The Edwards Balloon Catheter is indicated for balloon pulmonic valvuloplasty.

Source page: https://510kreport.com/device/K153069
Methodology: https://510kreport.com/methodology