K241206 is an FDA 510(k) clearance for the Quantum Perfusion Hybrid System. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II - Special Controls, product code DTN).
Submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on July 18, 2024, 79 days after receiving the submission on April 30, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K241206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2024 |
| Decision Date | July 18, 2024 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |