FDA 510(k) Application Details - K123024

Device Classification Name Wire, Guide, Catheter

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510(K) Number K123024
Device Name Wire, Guide, Catheter
Applicant Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE, MN 55311 US
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Contact RACHEL OWENS
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 09/28/2012
Decision Date 10/26/2012
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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