pREBOA-PRO Catheter

pREBOA-PRO Catheter is an FDA 510(k)-cleared medical device (K200459) 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 June 2, 2020. Regulation: 8.