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.
FDA 510(k) Cleared Prosthesis, Tracheal, Expandable Devices (Product Code JCT)
About Product Code JCT - Regulatory Context
510(k) Submission Activity
45 total 510(k) submissions under product code JCT since 1991, with 45 receiving FDA clearance (average review time: 135 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
JCT devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →