K260635
- 510(k) number
- K260635
- Device name
- HARBOR Occlusion Device
- Applicant
- Nuvascular, Inc. CA · US
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2026-06-12
- Date received
- 2026-02-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260635.pdf
Official FDA record: K260635
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.