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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 K162970
Device Name FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator
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  
Date Received10/24/2016
Decision Date 11/22/2016
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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