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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 K221483
Device Name FlowSaver Blood Return System
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 Number868.5830
Classification Product Code
CAC  
Date Received05/23/2022
Decision Date 02/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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