FDA 510(k) Application Details - K040700

Device Classification Name Catheter, Percutaneous

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510(K) Number K040700
Device Name Catheter, Percutaneous
Applicant CONCENTRIC MEDICAL, INC.
1380 SHOREBIRD WAY
MOUNTAIN VIEW, CA 94043 US
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Contact KEVIN F MACDONALD
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 03/17/2004
Decision Date 06/21/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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