K242608
- 510(k) number
- K242608
- Device name
- Embozene Color-Advanced Microspheres
- Applicant
- Varian Medical Systems, Inc. CA · US
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2025-01-17
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K242608.pdf
Official FDA record: K242608
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.