K212657 is an FDA 510(k) clearance for the Quantum Heater-Cooler. This device is classified as a Controller, Temperature, Cardiopulmonary Bypass (Class II - Special Controls, product code DWC).
Submitted by Spectrum Medical , Ltd. (Gloucester, GB). The FDA issued a Cleared decision on May 6, 2022, 256 days after receiving the submission on August 23, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4250. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K212657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2021 |
| Decision Date | May 06, 2022 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWC - Controller, Temperature, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4250 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |