FDA 510(k) Application Details - K023878

Device Classification Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

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510(K) Number K023878
Device Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant MEDTRONIC VASCULAR
37A CHERRY HILL DR.
DANVERS, MA 01923 US
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Contact FRED L BOUCHER
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Regulation Number 870.1250

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Classification Product Code NFA
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Date Received 11/21/2002
Decision Date 01/24/2003
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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