# K152150: V8 Balloon Aortic Valvuloplasty Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Intervalve, Inc.
- Decided: Dec 18, 2015 after 137 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 DEN080015 (2012). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150343: V8 Transluminal BAV Catheter, Intervalve, Inc. (2015) Summary page 5.

## Indications for use
The V8 Balloon Aortic Valvuloplasty Catheter is indicated for Balloon Aortic Valvuloplasty.

Source page: https://510kreport.com/device/K152150
Methodology: https://510kreport.com/methodology