What Is It?
A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
How Is POL Classified?
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment is FDA product code POL, Class 2, 21 CFR 882.5600.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Do the Recalls Say?
The FDA has recorded 3 recalls under this product code since 2020. None was by a company in China. 1 is Class I, the most serious grade.
The root cause the FDA records most often is Process design (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.