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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 K192135
Device Name VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
Applicant
MicroVention, Inc.
1311 Valencia Ave.
Tustin,  CA  92780
Applicant Contact Sapna Singh
Correspondent
MicroVention, Inc.
1311 Valencia Ave.
Tustin,  CA  92780
Correspondent Contact Sapna Singh
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
KRA  
Date Received08/07/2019
Decision Date 12/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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