K242076
- 510(k) number
- K242076
- Device name
- VersaCross RF Wire
- Applicant
- Baylis Medical Company CA
- Product code
- DXF — Catheter, Septostomy
- Decision date
- 2024-11-01
- Date received
- 2024-07-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K242076.pdf
Official FDA record: K242076
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.