Cleared Traditional

pRESET LITE Thrombectomy Device

K231539 · Phenox Limited · Neurology

Oct 2023

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K231539 is an FDA 510(k) clearance for the pRESET LITE Thrombectomy Device, a Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (Class II — Special Controls, product code POL), submitted by Phenox Limited (Galway, IE). The FDA issued a Cleared decision on October 21, 2023, 144 days after receiving the submission on May 30, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5600.

Submission Details

510(k) Number	K231539 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2023
Decision Date	October 21, 2023
Days to Decision	144 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	POL — Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5600
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.