510(k) K884866

TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 by Oscor Medical Corp. — Product Code LDF

K884866 is an FDA 510(k) premarket notification submitted by Oscor Medical Corp. for the device "TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Oscor Medical Corp. has at least 10 other 510(k) clearances on record.