510(k) K213540 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
| Applicant | Qura S.R.L, Mirandola, IT |
| Decision | Substantially Equivalent, May 20, 2022 |
| Received | Nov 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213540
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.