K240934 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3). This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on March 12, 2026, 706 days after receiving the submission on April 5, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K240934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2024 |
| Decision Date | March 12, 2026 |
| Days to Decision | 706 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTZ — Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |