510(k) K251181 ยท DQX Wire, Guide, Catheter
Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSW
| Applicant | Merit Medical Ireland, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Aug 29, 2025 |
| Received | Apr 16, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251181
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.