510(k) K896742

FOCUS J81F, J83F, J41F, J43F PACING LEADS by Ela Medical, Inc. — Product Code DTB

K896742 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "FOCUS J81F, J83F, J41F, J43F PACING LEADS". The FDA issued a decision of Substantially Equivalent on July 17, 1990. 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.