ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX is an FDA 510(k)-cleared medical device (K001346) manufactured by St. Jude Medical, 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 May 23, 2000. Regulation: 8.