TriSalus TriGuideTM Guiding Catheter

TriSalus TriGuideTM Guiding Catheter is an FDA 510(k)-cleared medical device (K233858) manufactured by Trisalus Life Sciences. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 2023. Regulation: 8.