JOSTRA HLM TUBING SETS WITH SAFELINE COATING

JOSTRA HLM TUBING SETS WITH SAFELINE COATING is an FDA 510(k)-cleared medical device (K061832) 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 August 10, 2006. Regulation: 8.