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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 K090335
Device Name HD GUIDE CATHETER
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
DQY  
Date Received02/10/2009
Decision Date 05/06/2009
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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