K260292
- 510(k) number
- K260292
- Device name
- HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- Applicant
- Atraverse Medical CA · US
- Product code
- DXF — Catheter, Septostomy
- Decision date
- 2026-02-27
- Date received
- 2026-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260292.pdf
Official FDA record: K260292
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.