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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K063774
Device Name MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
Applicant
CONCENTRIC MEDICAL, INC.
1380 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact KIRSTEN VALLEY
Correspondent
CONCENTRIC MEDICAL, INC.
1380 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact KIRSTEN VALLEY
Regulation Number870.1250
Classification Product Code
NRY  
Date Received12/21/2006
Decision Date 01/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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