K232934
- 510(k) number
- K232934
- Device name
- Sunsphere
- Applicant
- Hangzhou Yangshun Medical Technology Co.,Ltd CN
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2024-05-30
- Date received
- 2023-09-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232934.pdf
Official FDA record: K232934
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.