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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K210176
Device Name FlowSaver Blood Filter
Applicant
Inari Medical
9 Parker, Suite 100
Irvine,  CA  92618
Applicant Contact Eben Gordon
Correspondent
Inari Medical
9 Parker, Suite 100
Irvine,  CA  92618
Correspondent Contact Eben Gordon
Regulation Number868.5830
Classification Product Code
CAC  
Date Received01/22/2021
Decision Date 07/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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