510(k) DEN250042 ยท SIU Predictive Indicator For Long-Term Cardiovascular Outcomes
CaRi-Heart
| Applicant | Caristo Diagnostics , Ltd., Stamford CT, US |
| Decision | Unknown, Jul 28, 2026 |
| Received | Sep 4, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250042
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.