510(k) K941921 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550
| Applicant | Medtronic Bio-Medicus, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jul 20, 1994 |
| Received | Apr 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941921
| 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.