510(k) K241414 ยท DXF Catheter, Septostomy
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)
| Applicant | Circa Scientific, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Sep 26, 2024 |
| Received | May 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241414
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.