Materials, Repair Or Replacement, Pacemaker

FDA product code KFJ · Class III (high risk) · 21 CFR 870.3710 · Cardiovascular

3510(k) clearances
0PMA approvals
0recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K913919Universal Terminal Cap, 3.2MMKFJ · Traditional Telectronics Pacing Systems, Inc.12/31/1991SE
K852236Medtronic Model 5867-1AKFJ · Traditional Medtronic Vascular07/11/1985SE
K813518Implant Aid Splicing Crimp & SleeveKFJ · Traditional Intermedics, Inc.01/12/1982SE