
Cook, Inc.
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ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE is an FDA 510(k)-cleared medical device (K140593) manufactured by Cook, Inc.. 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 December 14, 2014. Regulation: 8.