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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 K102657
Device Name CONCENTRIC BALLOON GUIDE CATHETER
Applicant
CONCENTRIC MEDICAL, INC.
301 E. EVELYN AVE.
MOUNTAIN VIEW,  CA  94041
Applicant Contact KIRSTEN VALLEY
Correspondent
CONCENTRIC MEDICAL, INC.
301 E. EVELYN AVE.
MOUNTAIN VIEW,  CA  94041
Correspondent Contact KIRSTEN VALLEY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/15/2010
Decision Date 11/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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