FDA 510(k) Application Details - K945379

Device Classification Name Wire, Guide, Catheter

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510(K) Number K945379
Device Name Wire, Guide, Catheter
Applicant BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN, MA US
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Contact MARY P LEGRAW
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/02/1994
Decision Date 06/05/1995
Decision SE - Substantially Equivalent
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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