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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 K232542
Device Name Wedge XL Delivery Catheter
Applicant
MicroVention, Inc.
35 Enterprise
Aliso Veijo,  CA  92656
Applicant Contact Alick Tan
Correspondent
MicroVention, Inc.
35 Enterprise
Aliso Veijo,  CA  92656
Correspondent Contact Alick Tan
Regulation Number870.1250
Classification Product Code
QJP  
Date Received08/22/2023
Decision Date 05/16/2024
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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