510(k) K001346

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX by St. Jude Medical, Inc. — Product Code DYB

K001346 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX". The FDA issued a decision of Substantially Equivalent on May 24, 2000. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. St. Jude Medical, Inc. has at least 10 other 510(k) clearances on record.