Product code PCK
- Device name
- Pediatric Ventricular Assist Device
- Medical specialty
- Cardiovascular
- Device class
- f
- Regulation number
- 870.3545
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
- Source
- FDA openFDA device classification dataset