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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 K040700
Device Name CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037
Applicant
Concentric Medical, Inc.
1380 Shorebird Way
Mountain View,  CA  94043
Applicant Contact KEVIN F MACDONALD
Correspondent
Concentric Medical, Inc.
1380 Shorebird Way
Mountain View,  CA  94043
Correspondent Contact KEVIN F MACDONALD
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/17/2004
Decision Date 06/21/2004
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
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