
Avalon Laboratories, LLC
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AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR is an FDA 510(k)-cleared medical device (K081820) manufactured by Avalon Laboratories, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 2008. Regulation: 8.