K231554
- 510(k) number
- K231554
- Device name
- UniPearls® Embolic Microspheres
- Applicant
- Suzhou Haowei Medical Technology Co., Ltd. CN
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2023-11-14
- Date received
- 2023-05-30
- 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: K231554.pdf
Official FDA record: K231554
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.