FDA 510(k) Application Details - K151840

Device Classification Name Wire, Guide, Catheter

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510(K) Number K151840
Device Name Wire, Guide, Catheter
Applicant Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311-1566 US
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Contact Nikki M Wahlberg
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/06/2015
Decision Date 12/16/2015
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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