FDA 510(k) Application Details - K201487

Device Classification Name Guide, Wire, Catheter, Neurovasculature

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510(K) Number K201487
Device Name Guide, Wire, Catheter, Neurovasculature
Applicant Micro Vention Inc.
35 Enterprise
Aliso Viejo, CA 92656 US
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Contact Ganesh Balachandar
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Regulation Number 870.1330

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Classification Product Code MOF
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Date Received 06/04/2020
Decision Date 07/02/2020
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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