Mayumi Thrombectomy System— 510(k) K254035

Name: FDA 510(k) clearance K254035
Creator: U.S. Food and Drug Administration
Published: 2026-09-03

Substantially Equivalent

MicroVention, Inc., d/b/a Terumo Neuro

FDA 510(k) clearance K254035 for Mayumi Thrombectomy System, Substantially Equivalent on 2026-09-03. Applicant: MicroVention, Inc., d/b/a Terumo Neuro. Device class: 2.

Clearance details

Applicant: MicroVention, Inc., d/b/a Terumo Neuro
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2025-12-16
Decision date: 2026-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QEZ

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K261105 — Powered Aventus Thrombectomy System2026-07-27
K262030 — Aventus Thrombectomy System2026-07-15
K253589 — Liberant RX Aspiration Catheter2026-04-23
K254208 — FLOWRUNNER Aspiration System2026-03-20
K253925 — Aventus Thrombectomy System2026-01-15

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Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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