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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
510(k) Number K213917
Device Name QStat Cartridge
Applicant
Hemosonics, LLC
400 Preston Ave.
Suite 250
Charlottesville,  VA  22903
Applicant Contact Iskra Mrakovic
Correspondent
Hemosonics, LLC
400 Preston Ave.
Suite 250
Charlottesville,  VA  22903
Correspondent Contact Garrett Sparks
Classification Product Code
QFR  
Date Received12/15/2021
Decision Date 11/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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