# K241562: OutFlo Aortic Valve Dilatation Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Disa Medinotec
- Decided: Mar 11, 2025 after 284 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: 5 generations back to K121083 (2012). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172932: True Flow Valvuloplasty Perfusion Catheter, C.R. Bard, Inc. (2017) Summary page 5.

## Indications for use
The OutFlo Aortic Valve Dilatation Balloon Catheter is indicated for balloon aortic valvuloplasty

Source page: https://510kreport.com/device/K241562
Methodology: https://510kreport.com/methodology