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510(k) K222848

pRESET Thrombectomy Device by Phenox Limited — Product Code POL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2023
Date Received
September 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device Class
Class II
Regulation Number
882.5600
Review Panel
NE
Submission Type

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.

Other clearances by Phenox Limited

  • K242676 — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (February 28, 2025)
  • K231539 — pRESET LITE Thrombectomy Device (October 21, 2023)
  • K191687 — pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (October 9, 2019)

Other clearances for product code POL

  • K242676 — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (February 28, 2025)
  • K231539 — pRESET LITE Thrombectomy Device (October 21, 2023)
  • K223305 — Trevo NXT ProVue Retriever (March 29, 2023)
  • K210502 — Trevo NXT ProVue Retriever (August 27, 2021)
  • K203358 — Solitaire X Revascularization Device (March 1, 2021)
  • K203219 — Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever (December 29, 2020)
  • K193576 — Solitaire Platinum Revascularization Device, Solitaire X Revascularization Devic (November 20, 2020)
  • K200117 — Trevo NXT ProVue Retriever (February 7, 2020)
  • K192207 — Trevo NXT ProVue Retriever (November 22, 2019)
  • K190779 — Trevo XP ProVue Retriever (June 25, 2019)