510(k) K012178 ยท CAC Apparatus, Autotransfusion
FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
| Applicant | Fresenius Hemotechnology, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Jul 23, 2001 |
| Received | Jul 12, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012178
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2003 | Fresenius Hemocare, Inc. ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir.
The component that is the subject of the recall is the AT1 Autotransfusi Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.