FDA 510(k) Application Details - K151554

Device Classification Name

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510(K) Number K151554
Device Name Occlusion Perfusion Catheter
Applicant ADVANCED CATHETER THERAPIES, INC.
25E. MAIN ST. SUITE 205
Chattanooga, TN 37408 US
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Contact PAUL JOSEPH FITZPATRIC
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Regulation Number

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Classification Product Code QEY
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Date Received 06/09/2015
Decision Date 09/15/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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