LifeFlow Rapid Infusion Device (LifeFlow Device)

LifeFlow Rapid Infusion Device (LifeFlow Device) is an FDA 510(k)-cleared medical device (K153731) manufactured by 410 Medical Innovation, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 2016. Regulation: 8.