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FDA 510(k) Application Details - K063785
Device Classification Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
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510(K) Number
K063785
Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant
EV3 INC
9600 54TH AVENUE NORTH
PLYMOUTH, MN 55442-2111 US
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Contact
David Worrell
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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
12/21/2006
Decision Date
01/19/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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