# K253855: KardiaPSI Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Intervention Tech, Inc. ; dba Corvention
- Decided: May 6, 2026 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122012: Z-Med Z-Med II, NuMED, Inc. (2012) Summary page 5.

## Indications for use
The KardiaPSI™ Balloon Catheter is indicated for Balloon Aortic Valvuloplasty.

Source page: https://510kreport.com/device/K253855
Methodology: https://510kreport.com/methodology