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510(k) Data Aggregation
K Number
K210862Device Name
Hemafuse System
Manufacturer
Sisu Global Health
Date Cleared
2021-07-29
(128 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
Sisu Global Health
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HEMAFUSE™ System is indicated for the collection of whole blood shed during a surgical procedure in which blood can be collected from the surgical field during periods of significant hemorrhage for purpose of reinfusion. It should only be used when performing surgery in remote military and austere military environments, when other sources of blood or autotransfusion are unavailable or thought inadequate for the need. Each Hemafuse System unit is indicated for a period of use no greater than 5 minutes.
Device Description
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