TrachFlush
Device Facts
| Record ID | K261499 |
|---|---|
| Device Name | TrachFlush |
| Applicant | Aw Technologies Aps |
| Product Code | BSK · Anesthesiology |
| Decision Date | Aug 13, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.