K261644
- 510(k) number
- K261644
- Device name
- Perfadex Plus
- Applicant
- Xvivo Perfusion AB SE
- Product code
- KDN — System, Perfusion, Kidney
- Decision date
- 2026-07-23
- Date received
- 2026-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261644.pdf
Official FDA record: K261644
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.