510(k) DEN250057 ยท SIF Software Device System For Estimation Of Cardiac Pressures
PCWP Analysis Software
| Applicant | Cardiosense, Inc., Chicago IL, US |
| Decision | Unknown, May 22, 2026 |
| Received | Nov 17, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250057
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.