K230284
- 510(k) number
- K230284
- Device name
- Penumbra LP Coil System
- Applicant
- Penumbra, Inc. CA · US
- Product code
- HCG — Device, Neurovascular Embolization
- Decision date
- 2023-10-25
- Date received
- 2023-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230284.pdf
Official FDA record: K230284
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.