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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 K090085
Device Name MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
Applicant
Concentric Medical, Inc.
301 E. Evelyn Ave.
Mountain View,  CA  94041
Applicant Contact LARAINE PANGELINA
Correspondent
Concentric Medical, Inc.
301 E. Evelyn Ave.
Mountain View,  CA  94041
Correspondent Contact LARAINE PANGELINA
Regulation Number870.1250
Classification Product Code
NRY  
Date Received01/13/2009
Decision Date 02/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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