510(k) K984233 ยท CAC Apparatus, Autotransfusion
C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE
| Applicant | Fresenius Hemotechnology, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Feb 1, 1999 |
| Received | Nov 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984233
| 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.