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 Boston Scientific Scimed, Inc., Boston Scientific Corp and Boston Scientific Corporation.