510(k) K893866 ยท BTO Tube, Tracheostomy (W/Wo Connector)
HOOD PEDIATRIC TRACHEOSTOMY TUBE
| Applicant | Hood Laboratories, Pembroke MA, US |
| Decision | Substantially Equivalent, Aug 7, 1989 |
| Received | May 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2013 | Bryan Medical Inc Tracoe Mini 3.0mm Tube, for pediatric use.
Pediatric tracheostomy tube used to provide safe airway access. Terminated |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.