510(k) K871204 ยท BTR Tube, Tracheal (W/Wo Connector)
CUFFED TRACHEAL TUBE (MULTIPLE)
| Applicant | Mallinckrodt Critical Care, Argyle NY, US |
| Decision | Substantially Equivalent, Apr 21, 1987 |
| Received | Mar 25, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871204
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2023 | Covidien COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D.
The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for
airway management by oral/nasal intubation of the trac Open, Classified |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.