Mayumi Thrombectomy System— 510(k) K254035
Substantially EquivalentMicroVention, 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.
Summary
The Mayumi Thrombectomy System is from MicroVention, doing business as Terumo Neuro, and is filed under QEZ, aspiration thrombectomy catheters. The record doesn't give the system's components or dimensions.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
MicroVention filed from Aliso Viejo, California. Review took 261 calendar days (December 16, 2025 to September 3, 2026).
Clearance details
- Applicant
- MicroVention, Inc., d/b/a Terumo Neuro
- Product code
- Product code QEZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
Recent devices under product code QEZ
view allMore clearances from MicroVention, Inc., d/b/a Terumo Neuro
view allAdverse events under product code QEZ
product code QEZ- Death
- 24
- Total
- 24
Source: openFDA MAUDE database, through . 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.