510(k) K843730 ยท BTO Tube, Tracheostomy (W/Wo Connector)
SHILEY DISPOS. DECANNULATION PLUG W/SW/
| Applicant | Shiley, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Oct 19, 1984 |
| Received | Sep 24, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843730
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Covidien LLC Covidien Shiley Disposable Decannulation Plug
REF
DDCP
UDI-DI code: 10884522004060
Product Codes that include the Covidien Shiley Disposable Decannulation Plug are:
Product Number / UDI-DI code
4DCF Open, Classified |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.