# P910054: Inoue Balloon Catheter

- Pathway: PMA
- Applicant: Toray Industries (America), Inc.
- Decided: Jun 28, 1994 after 1,023 days
- Product code: MAD (Catheter, Percutaneous (Valvuloplasty))
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P910054
Methodology: https://510kreport.com/methodology