K242921
- 510(k) number
- K242921
- Device name
- 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
- Applicant
- Vitaltec Corporation TW
- Product code
- BTO — Tube, Tracheostomy (W/Wo Connector)
- Decision date
- 2025-06-10
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K242921.pdf
Official FDA record: K242921
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.