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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 K182531
Device Name ClotTriever Thrombectomy System
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 Received09/14/2018
Decision Date 10/10/2018
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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