510(k) K261529 ยท DYB Introducer, Catheter
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Intr
| Applicant | Hartman Medical Group, LLC, Birmingham AL, US |
| Decision | Substantially Equivalent, Jul 6, 2026 |
| Received | May 8, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261529
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.