← Product Code [QEZ](/productcode/QEZ) · K254035

# Mayumi™ Thrombectomy System (K254035)

_MicroVention, Inc., d/b/a Terumo Neuro · QEZ · Sep 3, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K254035

## Device Facts

- **Applicant:** MicroVention, Inc., d/b/a Terumo Neuro
- **Product Code:** [QEZ](/productcode/QEZ.md)
- **Decision Date:** Sep 3, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5150
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

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**Source:** [https://fda-staging.innolitics.com/device/K254035](https://fda-staging.innolitics.com/device/K254035)

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