INTRODUCER, PERCUTANEOUS -- MODIFICATION

INTRODUCER, PERCUTANEOUS -- MODIFICATION is an FDA 510(k)-cleared medical device (K924491) manufactured by Medamicus, 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 17, 1992. Regulation: 8.