NYT
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Tracheal, Expandable, Polymeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3720
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA 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.
- Adverse events (MAUDE)
- 2007: 12 · 2008: 3 · 2009: 13 · 2010: 6 · 2012: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RUSCH POLYFLEX STENT KIT (K013266) | Rusch Intl. | 2001-11-27 |
| RUSCH POLYFLEX STENT KIT (K982614) | Rusch Intl. | 1998-12-04 |
| RUSCH TRACHEAL BRONCHIAL Y STENT (K953593) | Rusch, Inc. | 1995-10-13 |
Track NYT automatically
Every clearance here is in the API, with alerts when new ones post.