AortaSTAT Occlusion Device

AortaSTAT Occlusion Device is an FDA 510(k)-cleared medical device (K210602) manufactured by Renalpro Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 2021. Regulation: 8.