K210669 is an FDA 510(k) clearance for the Quantum Mini Ventilation Module. This device is classified as a Gas Control Unit, Cardiopulmonary Bypass (Class II - Special Controls, product code DTX).
Submitted by Spectrum Medical , Ltd. (Gloucestershire, GB). The FDA issued a Cleared decision on May 4, 2021, 60 days after receiving the submission on March 5, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4300.
| 510(k) Number | K210669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2021 |
| Decision Date | May 04, 2021 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTX - Gas Control Unit, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4300 |