510(k) K240908 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
| Applicant | Spectrum Medical , Ltd., Gloucester, GB |
| Decision | Substantially Equivalent, Jul 8, 2025 |
| Received | Apr 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240908
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.