510(k) K252419 ยท DXF Catheter, Septostomy
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
| Applicant | Atraverse Medical, Inc., Cardiff By The Sea CA, US |
| Decision | Substantially Equivalent, Aug 27, 2025 |
| Received | Aug 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252419
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.