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510(k) Data Aggregation
K Number
K000456Device Name
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2
Manufacturer
HARVEST TECHNOLOGIES, LLC.
Date Cleared
2000-06-01
(111 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HARVEST TECHNOLOGIES, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991430Device Name
SMARTPREP CENTRIFUGE SYSTEM
Manufacturer
HARVEST TECHNOLOGIES, LLC.
Date Cleared
1999-05-28
(32 days)
Product Code
JQC
Regulation Number
862.2050Why did this record match?
Applicant Name (Manufacturer) :
HARVEST TECHNOLOGIES, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.
Device Description
SmartPReP Centrifuge System: Includes a table-top, self-decanting, swinging bucket centrifuge and processing disposable designed to allow for rapid automatic separation of plasma and platelets. The centrifuge spins at a maximum speed of 6000 rpms at a maximum force of approximately 3550g.
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K Number
K983022Device Name
SMARTCELL PROCESSING SYSTEM
Manufacturer
HARVEST TECHNOLOGIES, LLC.
Date Cleared
1999-04-02
(214 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
HARVEST TECHNOLOGIES, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartCell™ Processing System is indicated for the processing of autologous shed blood collected intraoperatively or postoperatively to obtain concentrated red blood cells for reinfusion.
Device Description
The SmartCell System includes the following two components: Reusable SC-1000, SmartCell hardware system that includes the following major system components: start/stop/clear buttons, process indicator display, process indicator lights, HES and blood pumps, two processing chambers (left and right), fluid sensors, optics and drain controls. The system also includes the electronic components and system software that monitors proper installation of the disposable and the sedimentation process. The SCP-1500, Process Pack: a sterile, disposable device to transfer and contain the blood and sedimentation fluid (HES) during concentration and transfer to the preconnected filtered reinfusion bag. Also a separate disposable Processing Bag (SCP-1550) is provided that is a sub-assembly of the Process Pack. The SCP-1550 is provided to allow for processing of additional volumes of blood.
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