510(k) K260756 ยท EZL Catheter, Retention Type, Balloon
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
| Applicant | Sentinel Medical Technologies,, Jacksonville FL, US |
| Decision | Substantially Equivalent, Sep 4, 2026 |
| Received | Mar 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260756
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.