Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
POL · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5600
Classification
FDA Product Code
POL
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5600
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.