FDA 510(k) Application Details - K051880

Device Classification Name

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510(K) Number K051880
Device Name RIO ASPIRATION CATHETER
Applicant BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW, CA 94043-4655 US
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Contact CATHERINE A PETERS
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Regulation Number

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Classification Product Code QEZ
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Date Received 07/11/2005
Decision Date 01/04/2006
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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