pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device— 510(k) K242676

Name: FDA 510(k) clearance K242676
Creator: U.S. Food and Drug Administration
Published: 2025-02-28

Substantially Equivalent

Phenox Limited

FDA 510(k) clearance K242676 for pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device, Substantially Equivalent on 2025-02-28. 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: 2024-09-06
Decision date: 2025-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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K210502 — Trevo NXT ProVue Retriever2021-08-27
K203358 — Solitaire X Revascularization Device2021-03-01

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