FDA 510(k) Application Details - K182233

Device Classification Name

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510(K) Number K182233
Device Name FlowTriever Retrieval/Aspiration System
Applicant Inari Medical
9272 Jeronimo Rd., Suite 124
Irvine, CA 92618 US
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Contact Eben Gordon
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Regulation Number

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Classification Product Code QEW
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Date Received 08/17/2018
Decision Date 10/15/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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