FDA 510(k) Application Details - K150616

Device Classification Name Catheter, Thrombus Retriever

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510(K) Number K150616
Device Name Catheter, Thrombus Retriever
Applicant Concentric Medical, Inc.
301 East Evelyn Avenue
Mountain View, CA 94041 US
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Contact Rhoda M. Santos
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Regulation Number 870.1250

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Classification Product Code NRY
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Date Received 03/10/2015
Decision Date 06/12/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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