Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select

Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select is an FDA 510(k)-cleared medical device (K153430) manufactured by Cook Incorporated. 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 6, 2016. Regulation: 8.