Search Results

The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of braided wire of biomedical superalloy, in some cases partially covered by a polymeric covering. Some models include a radiopaque core. The stent's purpose is to maintain or increase the luminal diameter of the passage in which it is implanted. The stent is placed by means of a delivery system, which is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner by retraction of the outer tube.

This document is a 510(k) premarket notification correction letter for multiple Boston Scientific WALLSTENT® Endoprosthesis devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria because it's focused on establishing substantial equivalence to previously cleared devices and adding an MRI safety claim.

Therefore, the requested information cannot be extracted from the provided text. The document's purpose is regulatory clearance based on substantial equivalence, not performance evaluation against specific acceptance criteria.

Ask a specific question about this device