PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE

PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE is an FDA 510(k)-cleared medical device (K851665) manufactured by Pacesetter Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 1985. Regulation: 8.