FDA 510(k) Application Details - K211120

Device Classification Name Catheter, Thrombus Retriever

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510(K) Number K211120
Device Name Catheter, Thrombus Retriever
Applicant MicroVention Inc.
35 Enterprise
Aliso Viejo, CA 92656 US
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Contact Stephanie Onstot
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Regulation Number 870.1250

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Classification Product Code NRY
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Date Received 04/15/2021
Decision Date 03/31/2022
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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