K202125 is an FDA 510(k) clearance for the Century Perfusion System. This device is classified as a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II - Special Controls, product code DTQ).
Submitted by Century Hlm, LLC (Mesa, US). The FDA issued a Cleared decision on March 7, 2021, 219 days after receiving the submission on July 31, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4220.
| 510(k) Number | K202125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2020 |
| Decision Date | March 07, 2021 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTQ - Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4220 |