Radical the Dude 8F Guide Catheter

Radical the Dude 8F Guide Catheter is an FDA 510(k)-cleared medical device (K243577) manufactured by Maduro 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 January 13, 2025. Regulation: 8.