GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER

GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER is an FDA 510(k)-cleared medical device (K140028) 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 August 20, 2014. Regulation: 8.