K250508
- 510(k) number
- K250508
- Device name
- AK 98 Dialysis Machine (955607)
- Applicant
- Vantive US Healthcare, LLC IL · US
- Product code
- KDI — Dialyzer, High Permeability With Or Without Sealed D
- Decision date
- 2025-08-01
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K250508.pdf
Official FDA record: K250508
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.