510(k) K212688 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
| Applicant | Qura S.R.L, Mirandola, IT |
| Decision | Substantially Equivalent, Jan 10, 2022 |
| Received | Aug 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212688
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.