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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name peripheral mechanical thrombectomy with aspiration
510(k) Number K233815
Device Name ClotTriever Sheath
Applicant
Inari Medical, Inc.
6001 Oak Canyon, Suite 100
Irvine,  CA  92618
Applicant Contact Tosan Eweka
Correspondent
Inari Medical, Inc.
6001 Oak Canyon, Suite 100
Irvine,  CA  92618
Correspondent Contact Tosan Eweka
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Codes
DYB   KRA  
Date Received11/30/2023
Decision Date 12/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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