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FDA 510(k) Application Details - K013913
Device Classification Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
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510(K) Number
K013913
Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant
MEDTRONIC PERCUSURGE, INC.
530 MERCURY DR.
SUNNYVALE, CA 94085 US
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Contact
MATTHEW J MOON
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Regulation Number
870.1250
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Classification Product Code
NFA
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More FDA Info for this Product Code
Date Received
11/27/2001
Decision Date
11/15/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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