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Alveolus TB-STS Tracheobronchial Stent System

by Alveolus, Inc.

510(k) K033990

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK033990 Date12 May 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Alveolus Inc. Tb-Sts Tracheobronchial Stent System
510(k) Number
FDA Product Code
JCT
Device Class
Class II
Regulation
21 CFR Part 878.3720
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Alveolus TB-STS Tracheobronchial Stent System is a self-expanding, radiopaque nitinol stent fully covered with a biocompatible polyurethane membrane. It is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The device may include a delivery system and is supplied as a single-use device. It is regulated under FDA 510(k) clearance with product code JCT and is classified as a Class II device for tracheal prostheses. The special control for this device is FDA's Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Alveolus TB-STS Tracheobronchial Stent System used for?

    The TB-STS Tracheobronchial Stent System is indicated for the treatment of tracheobronchial strictures caused by malignant neoplasms. It is a self-expanding, radiopaque nitinol stent fully covered with a biocompatible polyurethane membrane designed to provide support and maintain airway patency.

  • How is the TB-STS Tracheobronchial Stent System supplied?

    The device is supplied as a single-use device and may include a delivery system. It is designed for one-time use only to ensure patient safety and device performance, as reuse could compromise the structural integrity of the stent and delivery system.

  • What is the regulatory status of the TB-STS Tracheobronchial Stent System?

    The device is regulated under FDA 510(k) clearance with product code JCT and is classified as a Class II device for tracheal prostheses. It received special control clearance based on FDA's Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.

  • Is the TB-STS Tracheobronchial Stent System sterile?

    The device is supplied as a sterile, single-use product. Sterility is maintained through the manufacturing and packaging process to prevent infection when implanted in patients, as it is intended for use in the treatment of tracheobronchial strictures.