# K142199: Ascendra Balloon Aortic Valvaloplasty Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: Oct 29, 2014 after 79 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.
No later device cites it as a predicate yet.
0 of 3 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 4.
- K122012: Z-Med Z-Med II, NuMED, Inc. (2012) Summary page 4.

## Indications for use
The Ascendra Balloon Aortic Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Source page: https://510kreport.com/device/K142199
Methodology: https://510kreport.com/methodology