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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 K192332
Device Name ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
Applicant
Inari Medical
9272 Jeronimo Rd., Suite 124
Irvine,  CA  92618
Applicant Contact Eben Gordon
Correspondent
Inari Medical
9272 Jeronimo Rd., Suite 124
Irvine,  CA  92618
Correspondent Contact Eben Gordon
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received08/27/2019
Decision Date 09/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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