510(k) K051303 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
BIO-CONSOLE, MODEL 560
| Applicant | Medtronic Perfusion Systems, Brooklyn Park MN, US |
| Decision | Substantially Equivalent, Jun 10, 2005 |
| Received | May 19, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051303
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2010 | Medtronic Cardiovascular Revascularization & Surgical Therap Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed Terminated |
DWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.