FDA 510(k) Application Details - K081305

Device Classification Name Catheter, Thrombus Retriever

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510(K) Number K081305
Device Name Catheter, Thrombus Retriever
Applicant CONCENTRIC MEDICAL, INC.
301 E. EVELYN AVE.
MOUNTAIN VIEW, CA 94041 US
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Contact KIRSTEN VALLEY
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Regulation Number 870.1250

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Classification Product Code NRY
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Date Received 05/08/2008
Decision Date 06/05/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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