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FDA 510(k)

Mayumi™ Thrombectomy System

K-Number: K254035 · 2026-09-03

ApplicantMicroVention, Inc., d/b/a Terumo Neuro
Decision Date2026-09-03
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mayumi™ Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc., d/b/a Terumo Neuro. It received FDA 510(k) clearance on 2026-09-03 under 510(k) number K254035. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mayumi™ Thrombectomy System?

Mayumi™ Thrombectomy System is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is MicroVention, Inc., d/b/a Terumo Neuro. The 510(k) number is K254035.

When did Mayumi™ Thrombectomy System receive FDA 510(k) clearance?

Mayumi™ Thrombectomy System received FDA 510(k) clearance on 2026-09-03, under 510(k) number K254035.

Who is the listed applicant for Mayumi™ Thrombectomy System?

The FDA 510(k) record lists MicroVention, Inc., d/b/a Terumo Neuro as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mayumi™ Thrombectomy System?

The FDA product code for Mayumi™ Thrombectomy System is QEZ.

Other records listing MicroVention, Inc., d/b/a Terumo Neuro as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QEZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261105Powered Aventus Thrombectomy System™Inquis MedicalK262030Aventus Thrombectomy SystemInquis MedicalK253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.K253925Aventus Thrombectomy SystemInquis MedicalK252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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