FDA 510(k) Application Details - K133177

Device Classification Name Catheter, Percutaneous

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510(K) Number K133177
Device Name Catheter, Percutaneous
Applicant CONCENTRIC MEDICAL, INC.
301 EAST EVELYN AVENUE
MOUNTAIN VIEW, CA 94041 US
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Contact RHODA SANTOS
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 10/17/2013
Decision Date 02/25/2014
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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