K242974
- 510(k) number
- K242974
- Device name
- External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
- Applicant
- Sophysa FR
- Product code
- JXG — Shunt, Central Nervous System And Components
- Decision date
- 2025-06-20
- Date received
- 2024-09-26
- 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: K242974.pdf
Official FDA record: K242974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.