K230775
- 510(k) number
- K230775
- Device name
- SOFIA EX Intracranial Support Catheter
- Applicant
- MicroVention, Inc. CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2023-09-14
- Date received
- 2023-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K230775.pdf
Official FDA record: K230775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.