SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO

SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO is an FDA 510(k)-cleared medical device (K863476) manufactured by Scimed Life Systems, Inc.. 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 24, 1986. Regulation: 8.