K234123
- 510(k) number
- K234123
- Device name
- Easi-Vue® embolic microspheres System
- Applicant
- Abk Biomedical, Inc. CA
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2024-02-13
- Date received
- 2023-12-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K234123.pdf
Official FDA record: K234123
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.