510(k) K251007 ยท DXF Catheter, Septostomy
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
| Applicant | Circa Scientific, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, May 1, 2025 |
| Received | Apr 1, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251007
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.