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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 K150366
Device Name SOFIA 6F Catheter
Applicant
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Applicant Contact NAOMI GONG
Correspondent
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Correspondent Contact NAOMI GONG
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
DQO  
Date Received02/12/2015
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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