NYT
- Product code
- NYT
- Device name
- Prosthesis, Tracheal, Expandable, Polymeric
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3720
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 3
FDA classification 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.
Official FDA classification page: NYT
Classification and pathway per current FDA publications. Data from openFDA (CC0).