FDA 510(k) Application Details - K161803

Device Classification Name Guide, Wire, Catheter, Neurovasculature

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510(K) Number K161803
Device Name Guide, Wire, Catheter, Neurovasculature
Applicant MICROVENTION, INC.
1311 VALENCIA AVENUE
TUSTIN, CA 92780 US
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Contact SAPNA SINGH
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Regulation Number 870.1330

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Classification Product Code MOF
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Date Received 06/30/2016
Decision Date 09/30/2016
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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