FDA product code OKR: Ventricular Bypass (Assist) Device
OKR is the FDA product code for ventricular bypass (assist) device. It is a Class III device, regulated under 21 CFR 870.3545 and reviewed by the Cardiovascular panel. Devices under OKR reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ventricular Bypass (Assist) Device |
| Device class | Class III |
| Regulation | 21 CFR 870.3545 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
Recalls for OKR devices
openFDA lists no recalls for product code OKR.
Frequently asked questions
What is FDA product code OKR?
OKR is the FDA product code for ventricular bypass (assist) device. It is a Class III device, regulated under 21 CFR 870.3545 and reviewed by the Cardiovascular panel.
What device class is OKR?
Class III, regulation 21 CFR 870.3545. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OKR
- Run a recall and safety report across every OKR manufacturer
- Watch product code OKR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.