JCT · Class II · 21 CFR 878.3720

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.

45
Total
45
Cleared
135d
Avg days
1991
Since
45 devices
25–45 of 45
No devices found for this product code.