K231664
- 510(k) number
- K231664
- Device name
- IRRAflow Active Fluid Exchange System (AFES)
- Applicant
- Irras USA, Inc. CA · US
- Product code
- JXG — Shunt, Central Nervous System And Components
- Decision date
- 2023-10-19
- Date received
- 2023-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231664.pdf
Official FDA record: K231664
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.