The following data is part of a premarket notification filed by Medtronic with the FDA for Bio-console, Model 560.
| Device ID | K070286 |
| 510k Number | K070286 |
| Device Name: | BIO-CONSOLE, MODEL 560 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | Medtronic 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Cheryl Norton |
| Correspondent | Cheryl Norton Medtronic 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-29 |
| Decision Date | 2007-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994757616 | K070286 | 000 |
| 00613994258090 | K070286 | 000 |
| 00613994258106 | K070286 | 000 |
| 00613994258113 | K070286 | 000 |
| 00613994258120 | K070286 | 000 |
| 00613994258250 | K070286 | 000 |
| 00613994450326 | K070286 | 000 |
| 00613994450456 | K070286 | 000 |
| 00613994450463 | K070286 | 000 |
| 00643169315747 | K070286 | 000 |