Paragon 8F Balloon Guide Catheter

Paragon 8F Balloon Guide Catheter is an FDA 510(k)-cleared medical device (K232437) manufactured by Wallaby Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 12, 2023. Regulation: 8.