510(k) K131964 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jul 24, 2013 |
| Received | Jun 27, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131964
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2021 | Medtronic Perfusion Systems Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures. Open, Classified |
DWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.