KFJ — Materials, Repair Or Replacement, Pacemaker Class III

FDA Device Classification

FDA product code KFJ covers "Materials, Repair Or Replacement, Pacemaker", a Class III medical device regulated under 21 CFR 870.3710. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.