510(k) K250821 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
| Applicant | Eurosets S.R.L, Medolla, IT |
| Decision | Substantially Equivalent, Dec 12, 2025 |
| Received | Mar 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250821
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.