510(k) K024053

PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB by Oscor, Inc. — Product Code DTB

K024053 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB". The FDA issued a decision of Substantially Equivalent on January 31, 2003. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Oscor, Inc. has at least 10 other 510(k) clearances on record.