SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW

SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW is an FDA 510(k)-cleared medical device (K902404) manufactured by 3M Company. 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 16, 1990. Regulation: 8.