Definition: The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls.
| Device Type ID | 5787 |
| Device Name | Prosthesis, Tracheal, Preformed/molded |
| 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 Description | Tracheal Prosthesis. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NWA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5787 |
| Device | Prosthesis, Tracheal, Preformed/molded |
| Product Code | NWA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tracheal Prosthesis. |
| CFR Regulation Number | 878.3720 [🔎] |