510(k) K251385 ยท DQX Wire, Guide, Catheter
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
| Applicant | Merit Medical Ireland, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Jan 21, 2026 |
| Received | May 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251385
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.