DeviceClearance

Product code POL— Neurology

Trevo NXT ProVue Retriever

Classification name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device class
Class 2
Regulation
21 CFR 882.5600
Advisory panel
Neurology
Total cleared
18
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code POL under 21 CFR 882.5600, via openFDA

Market context for product code POL

FDA has cleared 18 devices under product code POL between 2016 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code POL

Recent clearances under product code POL

Data sourced from openFDA. This site is unofficial and independent of the FDA.