# K963241: Ultraflex

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 14, 1996 after 87 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
No predicates in its family tree.
35 later devices descend from it; 9 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wallstent Tracheobronchial Stent System: named in the summary without a submission number
- (no number) Wallstent Tracheobronchial Endoprosthesis: named in the summary without a submission number

## Most influential descendants
- K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System (2001), 21 descendants of its own
- K030947: Alveolus Inc., TB-STS Tracheobronchial Stent System (2003), 18 descendants of its own
- K073266: Wallflex Partially Covered Esophageal Stent System (2008), 15 descendants of its own
- K033990: Alveolus Inc. TB-STS Tracheobronchial Stent System (2004), 15 descendants of its own
- K033053: Alveolus, TB-STS Tracheobronchial Stent System (2004), 15 descendants of its own

## Indications for use
The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K963241
Methodology: https://510kreport.com/methodology