# K254022: FLASH Flex™ Aorto-Ostial Angioplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Verge Medical, Inc.
- Decided: Apr 2, 2026 after 107 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- 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 K111284 (2011). 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)
- K152485: FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm, Ostial Corporation (2016) Summary page 6.

## Indications for use
Flash Flex Aorto-Ostial Angioplasty system is indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.

Source page: https://510kreport.com/device/K254022
Methodology: https://510kreport.com/methodology