510(k) K251783 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Inspire HCR and HCR DUAL cardiotomy reservoirs
| Applicant | Sorin Group Italia S.R.L., Mirandola (Modena), IT |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Jun 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251783
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.