K254221
- 510(k) number
- K254221
- Device name
- Optima Coil System (OptiOne Coil System)
- Applicant
- Balt USA, LLC CA · US
- Product code
- HCG — Device, Neurovascular Embolization
- Decision date
- 2026-01-27
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K254221.pdf
Official FDA record: K254221
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.