FDA 510(k) Application Details - K053116

Device Classification Name Catheter, Percutaneous

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510(K) Number K053116
Device Name Catheter, Percutaneous
Applicant BOSTON SCIENTIFIC CORP.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact MAUREEN MARY MONTBRIAND
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 11/07/2005
Decision Date 12/16/2005
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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