FDA 510(k) Application Details - K020283

Device Classification Name Wire, Guide, Catheter

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510(K) Number K020283
Device Name Wire, Guide, Catheter
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
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Contact JENNIFER BOLTON
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 01/28/2002
Decision Date 02/11/2002
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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