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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
Device Name HEADWAY DUO MICROCATHETER
Applicant
MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN,  CA  92780
Applicant Contact Naomi Gong
Correspondent
MICROVENTION, INC.
1311 VALENCIA AVE
TUSTIN,  CA  92780
Correspondent Contact Naomi Gong
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/27/2012
Decision Date 08/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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