IMPLANTAID LEAD INTRODUCER #319-10 & 12

IMPLANTAID LEAD INTRODUCER #319-10 & 12 is an FDA 510(k)-cleared medical device (K812502) manufactured by Intermedics, 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 12, 1981. Regulation: 8.