KONTRON PERCUTAEOUS DOUBLE-LUMEN

KONTRON PERCUTAEOUS DOUBLE-LUMEN is an FDA 510(k)-cleared medical device (K802924) manufactured by Avco Medical Products. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 1981. Regulation: 8.