| Device |
prosthesis, tracheal, preformed/molded |
| Regulation Description |
Tracheal prosthesis. |
| Definition |
The device is intended to provide support to weakened or constricting airway walls. |
| Physical State |
The device is tubular and traditionally made of silicone. Devices can range roughly from 6-14mm in diameter and have lengths as small as 20 mm to lengths as long as 150mm. |
| Technical Method |
The device functions independently providing physical support to the constricting airway. |
| Target Area |
The target area is the tracheobronchial tree |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | NWA |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.3720
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
