510(k) K242451 ยท DYG Catheter, Flow Directed
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 9, 2024 |
| Received | Aug 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242451
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.