NYT — Prosthesis, Tracheal, Expandable, Polymeric Class II
FDA product code NYT covers "Prosthesis, Tracheal, Expandable, Polymeric", a Class II medical device regulated under 21 CFR 878.3720. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NYT
- Device Class
- Class II
- Regulation Number
- 878.3720
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.