K223879 is an FDA 510(k) clearance for the Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M). This device is classified as a Heat-exchanger, Cardiopulmonary Bypass (Class II - Special Controls, product code DTR).
Submitted by Quara S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on April 13, 2023, 107 days after receiving the submission on December 27, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4240.
| 510(k) Number | K223879 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2022 |
| Decision Date | April 13, 2023 |
| Days to Decision | 107 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTR - Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4240 |