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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
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