K252812
- 510(k) number
- K252812
- Device name
- UniPearls® Embolic Microspheres
- Applicant
- Suzhou Haowei Medical Technology Co., Ltd. CN
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2026-07-31
- Date received
- 2025-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K252812.pdf
Official FDA record: K252812
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.