SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT

SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT is an FDA 510(k)-cleared medical device (K951802) manufactured by Scimed Life 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 July 20, 1995. Regulation: 8.