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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 K172014
Device Name Wedge Microcatheter
Applicant
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Applicant Contact Chet Jones
Correspondent
MicroVention, Inc.
35 Enterprise
Aliso Viejo,  CA  92656
Correspondent Contact Marina Emond
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/03/2017
Decision Date 04/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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