510(k) K253652 ยท DYB Introducer, Catheter
Genie MAX Large Bore Introducer Sheath
| Applicant | Cultiv8 1, LLC, Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 22, 2026 |
| Received | Nov 20, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253652
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.