FDA product code QOC: Temporary Non-Roller Type Left Or Right Heart Support Blood Pump
QOC is the FDA product code for temporary non-roller type left or right heart support blood pump. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under QOC reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Providing temporary partial or full left or right heart circulatory support in addition to other treatments for patient during the declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Temporary Non-Roller Type Left Or Right Heart Support Blood Pump |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOC devices
openFDA lists no recalls for product code QOC.
Frequently asked questions
What is FDA product code QOC?
QOC is the FDA product code for temporary non-roller type left or right heart support blood pump. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is QOC?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOC
- Run a recall and safety report across every QOC manufacturer
- Watch product code QOC 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.