K960974 is an FDA 510(k) clearance for the COBE CENTURY PERFUSION PUMP. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II - Special Controls, product code DWB).
Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on July 14, 1997, 490 days after receiving the submission on March 11, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4370.
| 510(k) Number | K960974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1996 |
| Decision Date | July 14, 1997 |
| Days to Decision | 490 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4370 |