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Galt Medical
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TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT is an FDA 510(k)-cleared medical device (K112398) manufactured by Galt Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 2012. Regulation: 8.