510(k) K061212

BIOTRONIK ENDOCARDIAL PACING LEADS by Biotronik, Inc. — Product Code DTB

K061212 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "BIOTRONIK ENDOCARDIAL PACING LEADS". The FDA issued a decision of Substantially Equivalent on July 10, 2006. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Biotronik, Inc. has at least 10 other 510(k) clearances on record.