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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 K113260
Device Name MODIFIED CONCENTIRC MICROCATHETER
Applicant
CONCENTRIC MEDICAL, INC.
301 E. EVELYN AVE.
MOUNTAIN VIEW,  CA  94041
Applicant Contact KIRSTEN VALLEY
Correspondent
CONCENTRIC MEDICAL, INC.
301 E. EVELYN AVE.
MOUNTAIN VIEW,  CA  94041
Correspondent Contact KIRSTEN VALLEY
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/04/2011
Decision Date 03/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
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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