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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K161803
Device Name Traxcess .007 Mini Guidewire
Applicant
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Applicant Contact SAPNA SINGH
Correspondent
MicroVention, Inc.
1311 Valencia Ave.
Tistin,  CA  92780
Correspondent Contact SAPNA SINGH
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received06/30/2016
Decision Date 09/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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