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 Exhau
| Device Type ID | 5792 |
| Device Name | Prosthesis, Tracheal, Expandable, Polymeric |
| Physical State | The Device Is A Self-expanding Tubular Device, 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 | NYT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5792 |
| Device | Prosthesis, Tracheal, Expandable, Polymeric |
| Product Code | NYT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tracheal Prosthesis. |
| CFR Regulation Number | 878.3720 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
Stent | 3 |
Material Deformation | 2 |
Cover | 1 |
Partial Blockage | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 11 |