FDA 510(k) Application Details - K140273

Device Classification Name Catheter, Intravascular Occluding, Temporary

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510(K) Number K140273
Device Name Catheter, Intravascular Occluding, Temporary
Applicant BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact DIANE NELSON
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Regulation Number 870.4450

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Classification Product Code MJN
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Date Received 02/03/2014
Decision Date 07/22/2014
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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