510(k) K160735 ยท CAC Apparatus, Autotransfusion
CATSmart
| Applicant | Fresenius Kabi AG, Bad Homburg, DE |
| Decision | Substantially Equivalent, Sep 16, 2016 |
| Received | Mar 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160735
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2019 | Fenwal Inc Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits:
1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 91 Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.