OKR · Ventricular Bypass (Assist) Device
Cardiovascular · 21 CFR 870.3545 · Class 3
Overview
| Product Code | OKR |
|---|---|
| Device Name | Ventricular Bypass (Assist) Device |
| Regulation | 21 CFR 870.3545 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
Identification
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
