Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer is an FDA 510(k)-cleared medical device (K153533) manufactured by Galt Medical 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 July 4, 2016. Regulation: 8.