Bio-Medicus Pediatric Cannula and Introducers

Bio-Medicus Pediatric Cannula and Introducers is an FDA 510(k)-cleared medical device (K143083) 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 March 24, 2015. Regulation: 8.