The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Bio-console 560.
| Device ID | K080824 |
| 510k Number | K080824 |
| Device Name: | BIO-CONSOLE 560 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55432 |
| Contact | Preeti Jain |
| Correspondent | Preeti Jain MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55432 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994450319 | K080824 | 000 |
| 00763000167325 | K080824 | 000 |
| 00763000236526 | K080824 | 000 |
| 00763000236533 | K080824 | 000 |
| 00763000236540 | K080824 | 000 |
| 00763000135447 | K080824 | 000 |
| 00643169315822 | K080824 | 000 |
| 00643169315839 | K080824 | 000 |
| 00613994425041 | K080824 | 000 |
| 00763000301347 | K080824 | 000 |