510(k) K853294

CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA by Cardiac Control Systems, Inc. — Product Code DTB

K853294 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA". The FDA issued a decision of Substantially Equivalent on December 4, 1985. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Cardiac Control Systems, Inc. has at least 10 other 510(k) clearances on record.