510(k) K982650 ยท CAC Apparatus, Autotransfusion
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
| Applicant | Dideco S.P.A., North Attleboro MA, US |
| Decision | Substantially Equivalent, Dec 16, 1998 |
| Received | Jul 30, 1998 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K982650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2006 | Cobe Cardiovascular, Inc dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc. Terminated |
CAC | None listed |
| Sep 9, 2006 | Cobe Cardiovascular, Inc Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc. Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.