ER-REBOA PLUS Catheter

ER-REBOA PLUS Catheter is an FDA 510(k)-cleared medical device (K193440) manufactured by Prytime Medical Devices, 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 January 8, 2020. Regulation: 8.