FDA 510(k) Application Details - K150303

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K150303
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311 US
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Contact Melanie Raska
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 02/06/2015
Decision Date 06/15/2015
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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