# K980163: Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume Covering

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Mar 13, 1998 after 56 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: 4 generations back to K923119 (1992). 5 ancestors in all.
41 later devices descend from it; 1 cites it directly.
0 of 47 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.
- K964121: Wallstent Tracheobronchial Endoprosthesis, Boston Scientific Scimed, Inc. (1996) Summary page 4.

## Most influential descendants
- K982184: Wallstent Endoprosthesis (1998), 40 descendants of its own
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive (2001), 37 descendants of its own
- K073667: Niti-S Biliary Stent (2008), 23 descendants of its own
- K030107: 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM (2003), 11 descendants of its own
- K113551: Esophageal TTS Stent (2012), 10 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 intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. The Wallstent Tracheobronchial Endoprosthesis with Permalume® Covering is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K980163
Methodology: https://510kreport.com/methodology