Covidien, LLC · Class II · Cleared Oct 6, 2025
| K-number | K250173 |
| Device name | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) |
| Applicant | Covidien, LLC |
| Product code | BTR |
| Device class | Class II |
| Decision date | Oct 6, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 868.5730 |
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