K243264
- 510(k) number
- K243264
- Device name
- DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2025-04-25
- Date received
- 2024-10-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243264.pdf
Official FDA record: K243264
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.