The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-console 560 Extracorporeal Blood Pumping Console.
| Device ID | K131964 |
| 510k Number | K131964 |
| Device Name: | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-07-24 |
| Summary: | summary |