510(k) DEN230087

AMStent® Tracheobronchial Covered Stent System by Peytant Solutions, Inc. — Product Code SDB

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: October 16, 2024
Date Received: December 20, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tracheal Prosthesis With Cover Material Derived From Human Sources
Device Class: Class II
Regulation Number: 868.3721
Review Panel: AN
Submission Type

The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors.