510(k) K792035 ยท BTR Tube, Tracheal (W/Wo Connector)
FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
| Applicant | Bivona Medical Technologies, Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 26, 1979 |
| Received | Oct 10, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K792035
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2021 | Smiths Medical ASD Inc. Bivona Aire-Cuf Endotracheal Tube Terminated |
BTR | None listed |
| Aug 9, 2021 | Smiths Medical ASD Inc. Bivona Uncuffed Wire Endotracheal Tubes, Terminated |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.