510(k) K260751 ยท MOF Guide, Wire, Catheter, Neurovasculature
35 Helix Guidewire
| Applicant | Piraeus Medical, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 27, 2026 |
| Received | Mar 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260751
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.