Bio-Medicus Life Support Catheter and Introducer

Bio-Medicus Life Support Catheter and Introducer is an FDA 510(k)-cleared medical device (K201100) manufactured by Medtronic, 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 July 14, 2021. Regulation: 8.