510(k) K203424 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2
| Applicant | Qura S.R.L, Mirandola, IT |
| Decision | Substantially Equivalent, Dec 17, 2021 |
| Received | Nov 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203424
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.