FDA 510(k) Application Details - K173200

Device Classification Name Catheter, Thrombus Retriever

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510(K) Number K173200
Device Name Catheter, Thrombus Retriever
Applicant MicroVention, Inc.
1311 Valencia Avenue
Tustin, CA 92780 US
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Contact Naomi Gong
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Regulation Number 870.1250

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Classification Product Code NRY
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Date Received 10/02/2017
Decision Date 06/11/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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