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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 K010954
Device Name CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
Original Applicant
CONCENTRIC MEDICAL, INC.
2585 leghorn st.
moutian view,  CA  94043
Original Contact kevin macdonald
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/30/2001
Decision Date 10/09/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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