510(k) K261745 ยท DXF Catheter, Septostomy
LightningWire Transseptal Puncture System (TPS)
| Applicant | ElectroWire Medical, Lexington SC, US |
| Decision | Substantially Equivalent, Jun 26, 2026 |
| Received | May 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261745
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.