510(k) K242921 ยท BTO Tube, Tracheostomy (W/Wo Connector)
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; 5410500-541
| Applicant | Vitaltec Corporation, Taichung City, TW |
| Decision | Substantially Equivalent, Jun 10, 2025 |
| Received | Sep 24, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242921
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.