K251383
- 510(k) number
- K251383
- Device name
- Prestige Coil System (Prestige Packing Line Extension)
- Applicant
- Balt USA, LLC CA · US
- Product code
- KRD — Device, Vascular, For Promoting Embolization
- Decision date
- 2025-05-30
- Date received
- 2025-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251383.pdf
Official FDA record: K251383
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.