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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 K093160
Device Name HEADWAY 21 MICROCATHETER, MODEL: MC212150S
Original Applicant
MICROVENTION, INC.
1311 valencia ave
tustin,  CA  92780
Original Contact naomi gong
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/06/2009
Decision Date 11/05/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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