FDA product code QZU: Temporary Embolization Assist Device, Peripheral
QZU is the FDA product code for temporary embolization assist device, peripheral. It is a Class II device, regulated under 21 CFR 870.3325 and reviewed by the Cardiovascular panel. Devices under QZU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
Classification
| Field | Value |
|---|---|
| Device name | Temporary Embolization Assist Device, Peripheral |
| Device class | Class II |
| Regulation | 21 CFR 870.3325 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for QZU devices
openFDA lists no recalls for product code QZU.
Frequently asked questions
What is FDA product code QZU?
QZU is the FDA product code for temporary embolization assist device, peripheral. It is a Class II device, regulated under 21 CFR 870.3325 and reviewed by the Cardiovascular panel.
What device class is QZU?
Class II, regulation 21 CFR 870.3325. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QZU
- Run a recall and safety report across every QZU manufacturer
- Watch product code QZU 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.
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