510(k) K000763

PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 by Biotronik, GmbH & Co. — Product Code DTB

K000763 is an FDA 510(k) premarket notification submitted by Biotronik, GmbH & Co. for the device "PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051". The FDA issued a decision of ST on April 6, 2000. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Biotronik, GmbH & Co. has at least 10 other 510(k) clearances on record.