INTERSEPT*PREBYPASS FILTER

INTERSEPT*PREBYPASS FILTER is an FDA 510(k)-cleared medical device (K883086) manufactured by Medtronic Blood 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 September 15, 1988. Regulation: 8.