
Guidant Corp.
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GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 is an FDA 510(k)-cleared medical device (K983075) 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 March 2, 1999. Regulation: 8.