Cleared Special

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

K242676 · Phenox Limited · Neurology

Feb 2025

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K242676 is an FDA 510(k) clearance for the pRESET Delta Thrombectomy Device and pRESET Delta 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 February 28, 2025, 175 days after receiving the submission on September 6, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5600.

Submission Details

510(k) Number	K242676 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2024
Decision Date	February 28, 2025
Days to Decision	175 days
Submission Type	Special
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.