510(k) K261438 ยท DTZ Oxygenator, Cardiopulmonary Bypass
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
| Applicant | Eurosets S.R.L, Medolla, IT |
| Decision | Substantially Equivalent, Sep 14, 2026 |
| Received | Apr 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261438
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.