K240900
- 510(k) number
- K240900
- Device name
- HOTWIRE RF Guidewire
- Applicant
- Atraverse Medical CA · US
- Product code
- DXF — Catheter, Septostomy
- Decision date
- 2024-05-01
- Date received
- 2024-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240900.pdf
Official FDA record: K240900
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.