SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT

SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT is an FDA 510(k)-cleared medical device (K925608) 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 June 15, 1993. Regulation: 8.