AK 98 Dialysis Machine (955607)

AK 98 Dialysis Machine (955607) is an FDA 510(k)-cleared medical device (K250508) manufactured by Vantive US Healthcare, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 2025. Regulation: 8.