# DEN230087: AMStent® Tracheobronchial Covered Stent System

- Pathway: De Novo (Direct)
- Applicant: Peytant Solutions, Inc.
- Decided: Oct 16, 2024 after 301 days
- Product code: SDB (Tracheal Prosthesis With Cover Material Derived From Human Sources)
- Device class: 2
- Regulation: 21 CFR 868.3721
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The AMStent® Tracheobronchial Covered Stent System (AMStent® System) is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms in adult patients.

Source page: https://510kreport.com/device/DEN230087
Methodology: https://510kreport.com/methodology