The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Bio-console, Model 560.
| Device ID | K051303 |
| 510k Number | K051303 |
| Device Name: | BIO-CONSOLE, MODEL 560 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis, MN 55428 |
| Contact | Dawn M Stenstrom |
| Correspondent | Dawn M Stenstrom MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis, MN 55428 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-19 |
| Decision Date | 2005-06-10 |
| Summary: | summary |