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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 K110813
Device Name HEADWAY 27 MICROCATHETER
Applicant
MICRO VENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Applicant Contact Naomi Gong
Correspondent
MICRO VENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Correspondent Contact Naomi Gong
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/24/2011
Decision Date 08/05/2011
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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