510(k) K253146 ยท DQX Wire, Guide, Catheter
Hyperdrive 35 Guidewire
| Applicant | Rapid-Medical , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Sep 18, 2026 |
| Received | Sep 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253146
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.