# K945494: Wallstent (R) Tracheobronchial Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Mar 3, 1995 after 115 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: 1 generation back to K923119 (1992). 2 ancestors in all.
47 later devices descend from it; 3 cite it directly.
0 of 50 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.
- K923119: Wallstent Esophageal Prothesis, Schneider U.S. Stent Div. (1992) Summary page 4.

## Most influential descendants
- K961296: Wallstent Tracheobronchial Endoprosthesis (1996), 45 descendants of its own
- K964121: Wallstent Tracheobronchial Endoprosthesis (1996), 44 descendants of its own
- K980163: Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume Covering (1998), 41 descendants of its own
- K982184: Wallstent Endoprosthesis (1998), 40 descendants of its own
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive (2001), 37 descendants of its own

## Recalls of this device
- May 25, 2011 · Not classified · Z-2832-2011: Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-em

## Indications for use
The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K945494
Methodology: https://510kreport.com/methodology