510(k) K884394

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F by Ela Medical, Inc. — Product Code DTB

K884394 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F". The FDA issued a decision of Substantially Equivalent on December 8, 1988. 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.