SDB

Tracheal Prosthesis With Cover Material Derived From Human Sources

Product code

SDB

Device name

Tracheal Prosthesis With Cover Material Derived From Human Sources

Device class

Class 2

21 CFR

21 CFR 868.3721

Medical specialty

Anesthesiology

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

1

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-10-16.