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510(k) Data Aggregation

    K Number
    K992275
    Device Name
    FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1999-08-04

    (28 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.
    Device Description
    The Low Volume Hemoconcentrator is similar to the F Series F400 Hemoconcentrator. Both hemoconcentrators are hollow fiber-type filters and will be provided with and without a tubing set. The Low Volume Hemoconcentrator has an active membrane surface area of 0.35M2 and a priming volume of 27 ml.
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    K Number
    K970700
    Device Name
    FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1998-09-15

    (567 days)

    Product Code
    MSE
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hemoflow dialyzers are designed for use in acute or chronic hemodialysis therapies as either single use or multiple use.
    Device Description
    Fresenius Polysulfone Hemodialyzers
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    K Number
    K974584
    Device Name
    FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1998-05-14

    (157 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.
    Device Description
    The Fresenius Hemoflow Series Dialyzer, the same product as the F Series Hemoconcentrators, is a hollow fiber-type filter. Fresenius-produced polysulfone capillary fibers are bundled and potted with polyurethane into an artificial kidney jacket manufactured from polyurethane. Screw-type end caps, manufactured from polyurethane, have twist lock connectors for the connection of venous and arterial blood lines. Two filtrate ports are located on the filter adjacent to the filtrate chambers. The ports have Hansen-type fittings for connection of filtrate tubing. For hemoconcentration, only the filtrate port on the venous end of the filter is used; the other port on the arterial end is capped. There are four (4) models within the F Series Hemoconcentrators family. The difference between the four models in the F Series Hemoconcentrators is the number of fibers contained within the artificial kidney jacket. As the number of fibers contained in the filter increases, the diameter of the filter and the filtration capacity increases proportionally. Each model will be manufactured with a tubing set (F400TS, F500TS, F700TS, F800TS); other models will be manufactured with tubing adapter, only (F400, F500, F700, F800).
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    K Number
    K973378
    Device Name
    C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1997-11-03

    (56 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C.A.T.S (Continuous Autotransfusion Svstem) by Frescruus is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).
    Device Description
    The Fresenius C.A.T.S is a continuous autotransfusion system working on the principle of a continuous flow centrifuge. In this continuous system, the blood to be processed passes through a separation chamber that can be divided into several compartments in which different steps of the autotransfusion process (i.e.; plasma separation, resuspension with saline and reconcentration) are performed simultaneously, creating a continuous flow of blood through the system. The C.A.T.S device is comprised of two major components: Reusable Autotransfusion Device (electromechanical microprocessor controlled device) and Disposable AT1 Autotransfusion Set.
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    K Number
    K961465
    Device Name
    2008H ON LINE CLEARANCE MONITOR
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1997-07-03

    (442 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fresenius On Line Clearance Monitor is a module that is incorporated into the Fresenius 2008H hemodialysis equipment to be used during a dialysis treatment to determine dialyzer clearance efficiency using changes in conductivity of the dialysate solution. The Fresenius On Line Clearance Monitor is intended to be used as a module with the Fresenius 2008H hemodialysis machine for determination of dialysis treatment urea clearance efficiency using Sodium conductivity as the surrogate solute marker.
    Device Description
    The Fresenius On Line Clearance Monitor (OLC) is a module that is incorporated into the Fresenius 2008H hemodialysis equipment. The OLC consists of hardware modifications to the 2008H dialysate fluid circuit which includes a second conductivity probe in the effluent dialysate line and software. The dialyzer clearance determination is made using changes in dialysate conductivity (Sodium concentration). The software either increases or decreases the dialysate conductivity. This change in conductivity causes a sodium concentration gradient to be formed between the blood and dialysate sides of the dialyzer. Sodium is then either diffused into the blood or out of the blood depending whether the dialysate conductivity is high or low. Accurate conductivity readings of the inlet and outlet dialysate solution can be used to calculate the flux of sodium (or change in conductivity because of changes in sodium concentration) in the dialysate. This value can then be used to calculate the dialyzer clearance of sodium. The clearance of sodium has been used as a surrogate dialyzer performance solute since the beginning of dialysis since urea and Sodium (from NaCl) pass through the dialysis membrane at essentially the same rate. The use of the On Line Clearance Monitor is non invasive and is performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator and minimizes the need for blood based urea analysis and dialyzer performance determination.
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    K Number
    K955762
    Device Name
    PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1996-07-31

    (226 days)

    Product Code
    KPF
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961706
    Device Name
    P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1996-07-31

    (90 days)

    Product Code
    LKN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K941460
    Device Name
    FRESENIUS BLOOD TEMPERATURE MONITOR
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1996-07-03

    (831 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955423
    Device Name
    PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
    Manufacturer
    FRESENIUS USA, INC.
    Date Cleared
    1996-06-13

    (198 days)

    Product Code
    FKP
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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