510(k) K240934 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
| Applicant | Spectrum Medical S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Mar 12, 2026 |
| Received | Apr 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240934
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.