510(k) K212152 ยท DYB Introducer, Catheter
Prelude IDeal 9F Hydrophilic Sheath Introducer
| Applicant | Merit Medical Systems, South Jordan UT, US |
| Decision | Substantially Equivalent, Jan 7, 2022 |
| Received | Jul 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212152
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.