ADAPTING SLEEVE KIT MODEL 4023

ADAPTING SLEEVE KIT MODEL 4023 is an FDA 510(k)-cleared medical device (K921318) manufactured by Siemens-Pacesetter, 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 August 2, 1992. Regulation: 8.