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510(k) Data Aggregation

    K Number
    K012178
    Device Name
    FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
    Manufacturer
    FRESENIUS HEMOTECHNOLOGY, INC.
    Date Cleared
    2001-07-23

    (11 days)

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

    FRESENIUS HEMOTECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fresenius AT1 Autotransfusion Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The Fresenius Plasma Sequestration Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device 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 Reich Plasma (PRP). The Fresenius Plasma Sequestration Direction Draw Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Reich Plasma (PRP).
    Device Description
    The AT1 Autotransfusion Set includes the blood-washing chamber, adapters for mounting the set into the C.A.T.S. device, blood inlet line with stepped adapter, fluid lines; and the waste and reinfusion bags. The Plasma Sequestration Set (PSQ) includes the bags required for collection of plasma and platelet rich plasma and the lines/connectors for connection to the whole blood bag and connection to the AT1 Autotransfusion Set. The Plasma Sequestration Direct Draw Set (PSQ-DD) includes all the components included in the standard PSQ Set and additionally, a blood drawing/anticoagulant line assembly. The C.A.T.S Continuous Autotransfusion System device is an autotransfusion device 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 Pack Red Cells (PRC), Plasma (PLS) and Platelet i Rich Plasma (PRP).
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    K Number
    K984586
    Device Name
    FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
    Manufacturer
    FRESENIUS HEMOTECHNOLOGY, INC.
    Date Cleared
    1999-06-29

    (187 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS HEMOTECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATR 40 and ATR 120 Autotransfusion Reservoirs are indicated as autotransfusion reservoirs to collect, defoam, filter, and store blood prior to processing.
    Device Description
    The Fresenius ATR 40 and ATR 120 are 3 liter blood collection reservoirs, with 40 or 120 micron filters respectively. They are used for the collection of blood lost intra- or postoperalively in surgical procedures. Collection is performed by vacuum suction via appropriate tubing systems e.g. double lumen suction lines for aspiration and simultaneous anticoagulation or drainage adapters connected to wound drains. They are connected to the respective inlet connectors on top of the reservoir: two 1/4"-connectors (one vertical, one horizontal), luer female connector. All inlet connectors drain the fluid into a filter via a filter holder. The ATR 40 contains a three-layer filter and the ATR 120 contains a two-layer filter that traps particulates greater than 40 and 120 microns, respectively. In both filters, the PUR foam is treated with a defoaming agent to dissolve bubbles generated in the blood collection process by mixing blood with air. Except for the filter ATR 40 and ATR 120 are identical. The filters are attached to the filter holder by a cable tie and hang like a pouch in the reservoir lumen. The vacuum is applied via a separate vacuum line attached to a 1/4" vacuum port. Positive and negative pressure level within the reservoir is limited by a pressure relief valve that opens in the range of approximately -300 mmHg and + 100 mmHg. Up to 3 liters of aspirated blood can pass through the filter and be stored in the reservoir lumen at one time. The volume of collected blood can be controlled by calibration marks on both sides of the reservoir; the calibration marks are in increments of 100 ml to 3000 ml. Collected blood can be transferred to an autotransfusion device via the outlet line attached to the reservoir. The flow of blood through the outlet line can be controlled with a pinch clamp. A universal adapter, compatible with 1/4" male adapters and 3/8" female connectors, it attached to the distal end of the outlet line for connection to autotransfusion tubing sets. The reservoir can be attached to an IV pole using a compatible reservoir holder or the hanger on top of the reservoir. The ATR 40 and ATR 120 Autotransfusion Devices are supplied as sterile (ETO) disposable devices with a non-pyrogenic fluid path.
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    K Number
    K984233
    Device Name
    C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE
    Manufacturer
    FRESENIUS HEMOTECHNOLOGY, INC.
    Date Cleared
    1999-02-01

    (68 days)

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

    FRESENIUS HEMOTECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATS Suction Line is a suction line to aspirate and anticoagulate blood from the surgical field into an autotransfusion reservoir with ¼" suction port connected to a vacuum source. The ATY Y-Adapter is a Y-Adapter to connect two autotransfusion reservoirs with 1/4´´ female outlet connector to an autotransfusion device. The ATO Oxygenator Line is a tubing system to connect an oxygenator with 1/4´´ male connector to an autotransfusion device: - via a Y-adapter connected to an autotransfusion reservoir; or - directly to the autotransfusion device accepting a 1/4´´ female connector; or - via an autotransfusion reservoir.
    Device Description
    The ATS Suction Line consists of a double lumen tubing set for collection and anticoagulation of shed blood in surgery or trauma. The large tubing is used for aspiration of the shed blood. The small tubing welded to the large tubing provides anticoagulation. The large suction tube and small anticoagulation tube meet at the Yankauer adapter, to provide anticoagulation immediately after collection of blood. The suction line is connected to the appropriate collection reservoir by a ¼´´ female connector. The anticoagulant line is spiked to a anticoagulant container. Anticoagulant dosage is controlled by a roller clamp and regulates the drip rate of the anticoagulant into the drip chamber. The Yankauer adapter is designed to adapt to suction tips from 6.5 to 9.5 mm outer diameters. The ATY Y-Adapter is a disposable tubing set used to connect two autotransfusion reservoirs to an autotransfusion disposable set prior to processing. Each branch of the Y-Adapter may be attached to the blood outlet port of two reservoirs by 2 stepped ¼´´ adapters. Each branch connecting to the reservoirs has a pinch clamp to control flow to the autotransfusion device. The Y-Adapter outlet line has a universal adapter fitting for ¼´ male connectors or 3/8´´ female connectors. Alternatively, the ATY Y-Adapter can be used to connect one autotransfusion reservoir and one oxygenator line to an autotransfusion device. The ATO oxygenator line is a disposable tubing set for the collection or transfer of shed blood from the extracorporeal circulation (ECC) in cardiac surgery to an autotransfusion reservoir or to an autotransfusion device prior to processing. The is connected to the coronary perfusion port of an oxygenator prior to priming ECC. After conclusion of ECC, it may be connected to the free branch of a Y-adapter attached to an autotransfusion reservoir outlet, or directly to the blood inlet line of an autotransfusion device for direct processing. Alternatively it may be connected to a ¼" inlet connector of an autotransfusion reservoir to empty the oxygenator content into the reservoir prior to processing. All three devices are for single patient use, sterilized using ethylene oxide gas, and the fluid paths are non-pyrogenic.
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