K080824 is an FDA 510(k) clearance for the BIO-CONSOLE 560. This device is classified as a Control, Pump Speed, Cardiopulmonary Bypass (Class II - Special Controls, product code DWA).
Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on May 7, 2008, 44 days after receiving the submission on March 24, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4380.
| 510(k) Number | K080824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2008 |
| Decision Date | May 07, 2008 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWA — Control, Pump Speed, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4380 |