510(k) K240057 ยท EZL Catheter, Retention Type, Balloon
TraumaGuard Intra-abdominal Pressure Sensing System
| Applicant | Sentinel Medical Technologies, LLC, Jacksonville FL, US |
| Decision | Substantially Equivalent, Apr 17, 2024 |
| Received | Jan 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240057
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.