# K021901: Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Jul 9, 2002 after 29 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 K000001 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000001: Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System, Boston Scientific Scimed, Inc. (2000) Summary page 4.
- K003100: Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System, Boston Scientific Corp (2000) Summary page 4.

## Recalls of this device
- May 25, 2011 · Not classified · Z-2833-2011: 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 WALLGRAFT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K021901
Methodology: https://510kreport.com/methodology