Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set

Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set is an FDA 510(k)-cleared medical device (K142819) 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 July 23, 2015. Regulation: 8.