510(k) K240193 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
| Applicant | Sorin Group Italia S.R.L., Mirandola ( Modena), IT |
| Decision | Substantially Equivalent, Feb 22, 2024 |
| Received | Jan 24, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K240193
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.