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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 K122581
Device Name MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
Applicant
CONCENTRIC MEDICAL, INC.
301 E Evelyn Ave
MOUNTAIN VIEW,  CA  94041
Applicant Contact CHRISTINA ROWE
Correspondent
CONCENTRIC MEDICAL, INC.
301 E Evelyn Ave
MOUNTAIN VIEW,  CA  94041
Correspondent Contact CHRISTINA ROWE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/23/2012
Decision Date 11/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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