# K003100: Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 20, 2000 after 78 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021901: Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery System (2002), 0 descendants of its own

## 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

Source page: https://510kreport.com/device/K003100
Methodology: https://510kreport.com/methodology