FDA 510(k) Application Details - K231782

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K231782
Device Name Apparatus, Autotransfusion
Applicant Inari Medical, Inc.
6001 Oak Canyon, Suite 100
Irvine, CA 92618 US
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Contact Kaitlyn Weinkauf
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 06/16/2023
Decision Date 07/14/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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