FDA Product Code JCT: Prosthesis, Tracheal, Expandable
Tracheal reconstruction requires durable, biocompatible implants. FDA product code JCT covers expandable tracheal prostheses placed to restore airway patency.
These self-expanding stents or structured prostheses are deployed endoscopically or surgically to maintain an open tracheal lumen in patients with tracheal stenosis caused by prolonged intubation, trauma, tumors, or tracheomalacia.
JCT devices are Class II medical devices, regulated under 21 CFR 878.3720 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Micro-Tech (Nanjing) Co., Ltd. and Boston Scientific Corporation.
List of Prosthesis, Tracheal, Expandable devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Tracheal, Expandable devices (product code JCT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →