K251007
- 510(k) number
- K251007
- Device name
- CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
- Applicant
- Circa Scientific, Inc. CO · US
- Product code
- DXF — Catheter, Septostomy
- Decision date
- 2025-05-01
- Date received
- 2025-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251007.pdf
Official FDA record: K251007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.