# K141584: Ultraflex Tracheobronchial Covered Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Oct 16, 2014 after 125 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003173 (2001). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered, Boston Scientific Corp (2012) Summary page 4.
- K082284: Aero Tracheobronchial Stent Technology System, Alveolus, Inc. (2008) Summary page 4.
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730, Boston Scientific Corporation (2009) Summary page 5.

## Most influential descendants
- K230269: Ultraflex™ Tracheobronchial Stent System (2023), 0 descendants of its own

## Recalls of this device
- Mar 18, 2016 · Class II · Z-1567-2016: Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

## 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/K141584
Methodology: https://510kreport.com/methodology