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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K261549
Device Name BOBBY Balloon Guide Catheter
Applicant
MicroVention, Inc., d/b/a Terumo Neuro
35 Enterprise
Aliso Viejo,  CA  92656
Applicant Contact Miranda Beach
Correspondent
MicroVention, Inc., d/b/a Terumo Neuro
35 Enterprise
Aliso Viejo,  CA  92656
Correspondent Contact Miranda Beach
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received05/11/2026
Decision Date 06/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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