FDA 510(k) Application Details - K223613

Device Classification Name

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510(K) Number K223613
Device Name InThrill Thrombectomy System
Applicant Inari Medical, Inc
6001 Oak Canyon, Suite 100
Irvine, CA 92618 US
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Contact Ellen Nguyen
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Regulation Number

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Classification Product Code QEW
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Date Received 12/05/2022
Decision Date 03/17/2023
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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