510(k) K882345

PERMANENT PACING LEADS PYBJ SERIES by Oscor Medical Corp. — Product Code DTB

K882345 is an FDA 510(k) premarket notification submitted by Oscor Medical Corp. for the device "PERMANENT PACING LEADS PYBJ SERIES". The FDA issued a decision of Substantially Equivalent on October 28, 1988. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Oscor Medical Corp. has at least 10 other 510(k) clearances on record.