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510(k) Data Aggregation
K Number
K971710Device Name
ULTRACON ULTRAFILTRATOR
Manufacturer
QUANTIC BIOMEDICAL, INC.
Date Cleared
1998-02-27
(295 days)
Product Code
FJI
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
QUANTIC BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UltraCon™ Ultrafiltrator is indicated for use as an ultrafiltrator for the selective removal of undesireable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.
Device Description
The Ultracon™ Ultrafiltrator is constructed of semipermeable hollow fibers, which divide the device into two compartments. An inner pathway for diluted blood perfusate is defined by the inlet and outlet connectors and flow dispersion headers, which are connected through the inner lumen of semipermeable hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water.
When dilute blood or a blood component is allowed to pass through the perfusate pathway, the device acts as an ultrafilter, removing a percentage of the plasma water and small solutes from the perfusate. When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semipermeable membrane walls into the annular ultrafiltrate compartment, to then be discarded. This results in the concentration of formed elements and proteins as they pass along the perfusate pathway.
The UltraCon™ Ultrafiltrator is built with dry cellulose diacetate membranes, a unique material which has been shown to have a high level of biocompatibility. The absence of any bore fluid provides the convenience of using the device without the need for rinsing. Each device is supplied in a sealed plastic and foil package, to maintain a sterile, non-pyrogenic perfusate pathway.
Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraCon™ Ultrafiltrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary. Average ultrafiltration rate will vary directly according to perfusate flow rate, transmembrane pressure, or temperature, and inversely according to its protein concentration and hematocrit.
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