FDA 510(k) Application Details - K220600

Device Classification Name

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510(K) Number K220600
Device Name Artix Thrombectomy Device
Applicant Inari Medical
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 03/02/2022
Decision Date 03/25/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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