Product code OKR
- Device name
- Ventricular Bypass (Assist) Device
- Medical specialty
- Cardiovascular
- Device class
- 3
- Regulation number
- 870.3545
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for
- Source
- FDA openFDA device classification dataset