INFINITI™ Ambi Angiographic Catheter

INFINITI™ Ambi Angiographic Catheter is an FDA 510(k)-cleared medical device (K232573) manufactured by Cordis US Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2023. Regulation: 8.