K243998
- 510(k) number
- K243998
- Device name
- DCX Disposable Cassette (DCX)
- Applicant
- Institut Geroges Lopez FR
- Product code
- KDN — System, Perfusion, Kidney
- Decision date
- 2025-04-25
- Date received
- 2024-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243998.pdf
Official FDA record: K243998
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.