K242582
- 510(k) number
- K242582
- Device name
- Optima Coil System (OptiBlock Line Extension)
- Applicant
- Balt USA, LLC CA · US
- Product code
- HCG — Device, Neurovascular Embolization
- Decision date
- 2024-09-27
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K242582.pdf
Official FDA record: K242582
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.