QZU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Temporary Embolization Assist Device, Peripheral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3325
- Medical specialty
- Cardiovascular
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| BraidE Embolization Assist Device (DEN230064) | Rapid Medical Ltd. | 2024-02-21 |
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