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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
510(k) Number K182829
Device Name Scepter Mini Occlusion Balloon Catheter
Applicant
MicroVention, Inc.
35 Enterprise
Aliso Veijo,  CA  92656
Applicant Contact Marina Emond
Correspondent
MicroVention, Inc.
35 Enterprise
Aliso Veijo,  CA  92656
Correspondent Contact Marina Emond
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/05/2018
Decision Date 07/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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