FDA 510(k) Application Details - K063313

Device Classification Name Temporary Carotid Catheter For Embolic Capture

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510(K) Number K063313
Device Name Temporary Carotid Catheter For Embolic Capture
Applicant BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW, CA 94043 US
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Contact DONNA PAGE
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Regulation Number 870.1250

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Classification Product Code NTE
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Date Received 11/02/2006
Decision Date 12/05/2006
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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