510(k) K253034 ยท DQK Computer, Diagnostic, Programmable
HemoSphere Stream Module
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 21, 2025 |
| Received | Sep 22, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253034
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.