510(k) K960006 ยท CAC Apparatus, Autotransfusion
C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
| Applicant | Fresenius AG, Foster RI, US |
| Decision | Substantially Equivalent, Jul 31, 1996 |
| Received | Jan 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2010 | Fresenius Kabi, LLC The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phys Terminated |
CAC | None listed |
| Nov 10, 2010 | Fresenius Kabi, LLC The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phys Terminated |
CAC | None listed |
| Nov 10, 2010 | Fresenius Kabi, LLC The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a phy Terminated |
CAC | None listed |
| 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.