OKR · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.3545
Classification
FDA Product Code
OKR
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 870.3545
Review panel
CV
Medical specialty
Cardiovascular
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.