510(k) K250610 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Jun 27, 2025 |
| Received | Feb 28, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250610
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.