K250635
- 510(k) number
- K250635
- Device name
- FEops HEARTguide Simulation Application
- Applicant
- Feops NV BE
- Product code
- QQI — Interventional Cardiovascular Implant Simulation Sof
- Decision date
- 2025-11-25
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250635.pdf
Official FDA record: K250635
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.