510(k) K231982 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
| Applicant | Qura S.R.L, Mirandola, IT |
| Decision | Substantially Equivalent, Sep 12, 2024 |
| Received | Jul 5, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231982
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.