K250133
- 510(k) number
- K250133
- Device name
- HARBOR Occlusion Device
- Applicant
- Nuvascular, Inc. CA · US
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2025-07-09
- Date received
- 2025-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250133.pdf
Official FDA record: K250133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.