21 CFR 870.3325 — Temporary Embolization Assist Device, Peripheral
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3325
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QZU | Temporary Embolization Assist Device, Peripheral | 2 | 1 |
Special Controls
QZU — Temporary Embolization Assist Device, Peripheral
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:
De Novo Order DEN230064
