FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device

FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device is an FDA 510(k)-cleared medical device (K180588) manufactured by Teleflex Medical. 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 April 16, 2018. Regulation: 8.