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510(k) Data Aggregation
K Number
K942844Device Name
LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
Manufacturer
LEVEL 1 TECHNOLOGIES, INC.
Date Cleared
1996-04-26
(680 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
LEVEL 1 TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collection of patient's shed blood for Autotranstusion
Device Description
The Level 1 BloodStream Recovery System employs the same method of operation (vacuum/air flow) for the same indicated use. Construction of fluid path components is of bio-compatible plastics as in the predicate devices, and as in those devices, the fluid path is sterile. The Level 1 BloodStream Recovery System may be used with the same anti-coagulant and standard blood administration sets currently used with those devices.
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