510(k) K001413

ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 by Biotronik, Inc. — Product Code DTB

K001413 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668". The FDA issued a decision of ST on June 2, 2000. 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.