# K140241: Edwards Transfemoral Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jul 3, 2014 after 154 days
- Product code: OZT (Balloon Aortic Valvuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.1255
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K122012 (2012). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121083: True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True Dilatation Percutaneous Translumina, Loma Vista Medical (2012) Summary page 1.
- K122012: Z-Med Z-Med II, NuMED, Inc. (2012) Summary page 1.

## Most influential descendants
- K231814: ValvuloPro Valvuloplasty Balloon Catheter (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K140241
Methodology: https://510kreport.com/methodology