# K961507: Walstent Tracheobronchial Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Jul 10, 1996 after 82 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: 2 generations back to K923119 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934116: Wallstent Tracheobronchial Prosthesis Modification, Boston Scientific Scimed, Inc. (1994) Summary page 4.
- K945494: Wallstent (R) Tracheobronchial Endoprosthesis, Boston Scientific Scimed, Inc. (1995) Summary page 4.

## Indications for use
The Wallstent® Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures and fistulas produced by malignant neoplasms.

Source page: https://510kreport.com/device/K961507
Methodology: https://510kreport.com/methodology