K252700
- 510(k) number
- K252700
- Device name
- Optima Coil System (Optima Packing Coil System)
- Applicant
- Balt USA, LLC CA · US
- Product code
- HCG — Device, Neurovascular Embolization
- Decision date
- 2025-09-26
- Date received
- 2025-08-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252700.pdf
Official FDA record: K252700
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.