FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX

FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX is an FDA 510(k)-cleared medical device (K001367) 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 30, 2000. Regulation: 8.