510(k) K252441 ยท DYB Introducer, Catheter
Primero Safe Access System
| Applicant | South53, LLC, San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Sep 29, 2025 |
| Received | Aug 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252441
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.