pRESET Thrombectomy Device— 510(k) K222848

Substantially Equivalent

Phenox Limited

FDA 510(k) clearance K222848 for pRESET Thrombectomy Device, Substantially Equivalent on 2023-01-20. Applicant: Phenox Limited. Device class: 2.

Clearance details

Applicant: Phenox Limited
Product code: Code POL
Device class: Class 2
Regulation: 21 CFR 882.5600
Advisory panel: Neurology
Date received: 2022-09-21
Decision date: 2023-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code POL

K242676 — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device2025-02-28
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K223305 — Trevo NXT ProVue Retriever2023-03-29
K210502 — Trevo NXT ProVue Retriever2021-08-27
K203358 — Solitaire X Revascularization Device2021-03-01

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Data sourced from openFDA. This site is unofficial and independent of the FDA.