
Vygon Corp.
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DUALYSE-CATH - CODES #1132.212, 1132.112 is an FDA 510(k)-cleared medical device (K896568) manufactured by Vygon 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 May 8, 1990. Regulation: 8.