510(k) K972574

STELA MODEL UJ45 PACING LEADS by Ela Medical, Inc. — Product Code DTB

K972574 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "STELA MODEL UJ45 PACING LEADS". The FDA issued a decision of ST on January 8, 1998. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.