FDA 510(k) Application Details - K102657

Device Classification Name Catheter, Percutaneous

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510(K) Number K102657
Device Name Catheter, Percutaneous
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 DQY
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Date Received 09/15/2010
Decision Date 11/17/2010
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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