510(k) K896978 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
| Applicant | Medtronic Vascular, Anaheim CA, US |
| Decision | Substantially Equivalent, Feb 28, 1990 |
| Received | Dec 13, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2005 | Medtronic Perfusion Systems Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Terminated |
DWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.