510(k) K082520 ยท BTR Tube, Tracheal (W/Wo Connector)
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
| Applicant | Mallinckrodt Medical, Boulder CO, US |
| Decision | Substantially Equivalent, Oct 2, 2008 |
| Received | Sep 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082520
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2016 | Stryker Sustainability Solutions Mallinckrodt Evac Tracheal Tubes
Model #124170-MALLINCKRODT & 124175 Terminated |
BTR | None listed |
| Apr 4, 2016 | Stryker Sustainability Solutions Launcher Guiding Catheter
Model #LA6EBU30. Used in the coronary or peripheral vascular system.. Terminated |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.