Ventricular Bypass (Assist) Device
FDA product code OKR · Class III (high risk) · 21 CFR 870.3545 · Cardiovascular
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.
0510(k) clearances
0PMA approvals
0recalls