Temporary Embolization Assist Device, Peripheral
The temporary peripheral embolization assist device (product code QZU) is a Class 2 Cardiovascular prescription device (regulation 870.3325) intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils via an endovascular approach, and is removed from the body upon procedure completion. Requiring 510(k) clearance, it is not intended for permanent implantation, is not classified as an implant, and is not life-sustaining.
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Basic Information
- Product Code
- QZU
- Device Class
- FDA class 2
- Regulation Number
- 870.3325
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230064 | BraidE Embolization Assist Device | Feb 21, 2024 | Unknown | Rapid Medical , Ltd. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.