LEAD INTRODUCER SETS-EB-S8 & EB-S12

LEAD INTRODUCER SETS-EB-S8 & EB-S12 is an FDA 510(k)-cleared medical device (K831751) manufactured by Oscor, 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 October 19, 1983. Regulation: 8.