JOSTRA HLM TUBING SET

JOSTRA HLM TUBING SET is an FDA 510(k)-cleared medical device (K053025) manufactured by Maquet Cardiopulmonary, AG. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 9, 2005. Regulation: 8.