FDA 510(k) Application Details - K121774

Device Classification Name Catheter, Peripheral, Atherectomy

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510(K) Number K121774
Device Name Catheter, Peripheral, Atherectomy
Applicant BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact BETH TOROK
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Regulation Number 870.4875

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Classification Product Code MCW
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Date Received 06/18/2012
Decision Date 09/13/2012
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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