
Guidant Corp.
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GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 is an FDA 510(k)-cleared medical device (K991032) manufactured by Guidant Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 1999. Regulation: 8.