Aristotle Colossus Guidewire

Aristotle Colossus Guidewire is an FDA 510(k)-cleared medical device (K222437) manufactured by Scientia Vascular, 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 25, 2023. Regulation: 8.