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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 K230494
Device Name ClotTriever BOLD Catheter
Applicant
Inari Medical, Inc.
6001 Oak Canyon, Suite 100
Irvine,  CA  92618
Applicant Contact Kaitlyn Weinkauf
Correspondent
Inari Medical, Inc.
6001 Oak Canyon, Suite 100
Irvine,  CA  92618
Correspondent Contact Kaitlyn Weinkauf
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received02/23/2023
Decision Date 04/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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