QZU · Temporary Embolization Assist Device, Peripheral
Cardiovascular · 21 CFR 870.3325 · Class 2
Overview
| Product Code | QZU |
|---|---|
| Device Name | Temporary Embolization Assist Device, Peripheral |
| Regulation | 21 CFR 870.3325 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
The BraidE Embolization Assist Device is a sterile, single-use, prescription endovascular device intended for temporary use in the peripheral vasculature to mechanically assist in the coil embolization of wide-necked peripheral aneurysms (neck width ≤ 10 mm, defined as > 4 mm or a dome-to-neck ratio < 2). The device consists of a nitinol braided mesh, stainless steel shaft, nitinol core wire, and a handle. It is delivered via an endovascular approach, is not intended for permanent implantation, and is removed upon procedure completion.
Classification Rationale
Class II (special controls). The device is a temporary coil embolization assist device for peripheral vascular use, regulated under 21 CFR 870.3325.
Special Controls
In combination with the general controls of the FD&C Act, the temporary coil embolization assist device for peripheral vascular use is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230064 | BraidE Embolization Assist Device | Rapid Medical , Ltd. | Feb 21, 2024 | DENG |
Top Applicants
- Rapid Medical , Ltd. — 1 clearance
