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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K254035
Device Name Mayumi™ Thrombectomy System
Applicant
MicroVention, Inc., d/b/a Terumo Neuro
35 Enterprise
Aliso Viejo,  CA  92656
Applicant Contact Remya Krishnan
Correspondent
MicroVention, Inc., d/b/a Terumo Neuro
35 Enterprise
Aliso Viejo,  CA  92656
Correspondent Contact Remya Krishnan
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received12/16/2025
Decision Date 09/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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