QIK — Organ Care System (Ocs) Heart System Class III
FDA product code QIK covers "Organ Care System (Ocs) Heart System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QIK
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- No
Definition
A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient.