K232467
- 510(k) number
- K232467
- Device name
- CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
- Applicant
- Baxter Healthcare Corporation IL · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2023-09-14
- Date received
- 2023-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K232467.pdf
Official FDA record: K232467
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.