510(k) K021217

AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP by Biotronik, Inc. — Product Code DTB

K021217 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP". The FDA issued a decision of Substantially Equivalent on May 1, 2002. 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.