510(k) K212341 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U
| Applicant | Qura S.R.L, Mirandola, IT |
| Decision | Substantially Equivalent, Jan 28, 2022 |
| Received | Jul 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212341
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.