510(k) K260292 ยท DXF Catheter, Septostomy
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
| Applicant | Atraverse Medical, Cardiff By The Sea CA, US |
| Decision | Substantially Equivalent, Feb 27, 2026 |
| Received | Jan 29, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260292
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.