OKR — Ventricular Bypass (Assist) Device Class III
FDA product code OKR covers "Ventricular Bypass (Assist) Device", a Class III medical device regulated under 21 CFR 870.3545. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- OKR
- Device Class
- Class III
- Regulation Number
- 870.3545
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.