FDA 510(k) Application Details - K014223

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

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510(K) Number K014223
Device Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant MEDTRONIC PERCUSURGE, INC.
540 OAKMEAD PKWY.
SUNNYVALE, CA 94085 US
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Contact MATT MOON
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Regulation Number 870.1250

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Classification Product Code NFA
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Date Received 12/26/2001
Decision Date 01/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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