VitalStream ART Connect; VitalStream-Hemo

VitalStream ART Connect; VitalStream-Hemo is an FDA 510(k)-cleared medical device (K251275) manufactured by Caretaker Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 2025. Regulation: 8.