K192838 is an FDA 510(k) clearance for the Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure. This device is classified as a Control, Pump Speed, Cardiopulmonary Bypass (Class II - Special Controls, product code DWA).
Submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on April 13, 2020, 193 days after receiving the submission on October 3, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4380.
| 510(k) Number | K192838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2019 |
| Decision Date | April 13, 2020 |
| Days to Decision | 193 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 |