K250971
- 510(k) number
- K250971
- Device name
- Embosphere Microspheres
- Applicant
- Biosphere Medical, S.A. FR
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2025-05-16
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K250971.pdf
Official FDA record: K250971
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.