510(k) K252541 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
| Applicant | Spectrum Medical S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Mar 12, 2026 |
| Received | Aug 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252541
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.