Medical Device
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POLClass II

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

21 CFR 882.5600 / Neurology

POL is the FDA product code for Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment, a class II device type, regulated under 21 CFR 882.5600. FDA's definition for this code reads: "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...". As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
POL
Device name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
FDA 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.
Regulation
21 CFR 882.5600
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
3

Clearances, product code POL

By decision year
18 clearances under product code POL with a decision year between 2016 and 2025, 2019 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code POL by decision year
YearClearances
20162
20183
20194
20203
20212
20233
20251

Applicants with the most clearances

Product code POL
Applicants holding the most 510(k) clearances under product code POL
ApplicantClearances
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular6
Stryker Corp.6
Phenox Inc3
Concentric Medical, Inc.2
Medtronic Neurovascular1

Companies listing this code with FDA

Companies whose registered establishments list this code