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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 K210862
Device Name Hemafuse System
Applicant
Sisu Global Health
2720 Sisson St.
Baltimore,  MD  21211
Applicant Contact Gillian Henker
Correspondent
in2being, LLC
131 E Michigan Ave.
Suite E
Saline,  MI  48176
Correspondent Contact Adrienne Harris
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/23/2021
Decision Date 07/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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