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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(K) Number K120917
Models MC162157S, MC162168S
Device Name HEADWAY DUO MICROCATHETER
Applicant
MICROVENTION, INC.
1311 valencia ave
tustin,  CA  92780
Contact naomi gong
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/27/2012
Decision Date 08/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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