Product code QIK
- Device name
- Organ Care System (Ocs) Heart System
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient.
- Source
- FDA openFDA device classification dataset