K250276
- 510(k) number
- K250276
- Device name
- Nitinol Enhanced Device (NED)
- Applicant
- Embolization, Inc. CO · US
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2025-05-15
- Date received
- 2025-01-31
- 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: K250276.pdf
Official FDA record: K250276
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.