510(k) K180831 ยท CAC Apparatus, Autotransfusion
CATSmart
| Applicant | Fresenius Kabi AG, Bad Homburg, DE |
| Decision | Substantially Equivalent, Dec 10, 2018 |
| Received | Mar 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180831
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2019 | Fenwal Inc Vacuum Unit for CATSmart Vacuum Pump.
Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed p Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.