510(k) K250150 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
| Applicant | Sorin Group Italia S.R.L., Mirandola (Modena), IT |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Jan 21, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250150
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.