PREBYPASS FILTER CAT.#K-5

PREBYPASS FILTER CAT.#K-5 is an FDA 510(k)-cleared medical device (K803101) manufactured by Delta Medical Industries. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 1980. Regulation: 8.