# K230269: Ultraflex™ Tracheobronchial Stent System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jul 14, 2023 after 164 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003173 (2001). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141584: Ultraflex Tracheobronchial Covered Stent System, Boston Scientific Corporation (2014) Summary page 4.
- K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered, Boston Scientific Corp (2012) Summary page 4.

## Indications for use
The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K230269
Methodology: https://510kreport.com/methodology