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510(k) Data Aggregation

    K Number
    K020983
    Device Name
    JOSTRA SUCKERS, MODEL JS
    Manufacturer
    JOSTRA AG
    Date Cleared
    2004-01-30

    (674 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery lasting 6 hours or less.
    Device Description
    The Jostra Suction Devices are single, sterile devices for single use only and not to be resterilized by the user. The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery. The suction devices include rigid, flexible and pericardial suckers.
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    K Number
    K030264
    Device Name
    QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030
    Manufacturer
    JOSTRA AG
    Date Cleared
    2003-02-26

    (30 days)

    Product Code
    DTZ
    Regulation Number
    870.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
    Device Description
    The Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane (instead of polyethylene) which reduces the risk of electrostatic discharge for the patient significantly.
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    K Number
    K020784
    Device Name
    JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
    Manufacturer
    JOSTRA AG
    Date Cleared
    2003-01-09

    (304 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less. The Jostra Single Stage Venous Return Catheters are designed to be used for the collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to 6 hours or less.
    Device Description
    The Jostra Single Stage Venous Catheters are single, sterile devices for single use only and not to be resterilized by the user. The catheters are to be used to divert blood from the patient to the extracorporeal circuit by draining blood from the Inferior Vena Caya and the Superior Vena Cava. The catheters are made from polyvinyl chloride (PVC) and range in size from 12 Fr.- 40 Fr with a variety of tips and with or without attached connectors.
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    K Number
    K023132
    Device Name
    JOSTRA MECC SYSTEM
    Manufacturer
    JOSTRA AG
    Date Cleared
    2002-12-17

    (88 days)

    Product Code
    KFM
    Regulation Number
    870.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Mecc System is intended for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
    Device Description
    The Jostra Mecc System is a finished, sterile device for single use only and not to be restenlized by the user. The Jostra Mecc System is an extracorporeal circuit including circulatory and gas exchange support devices for use during extracorporeal circulation lasting 6 hours or less.
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    K Number
    K022022
    Device Name
    JOSTRA VENT CATHETERS, MODELS LV & HKV
    Manufacturer
    JOSTRA AG
    Date Cleared
    2002-09-11

    (83 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.
    Device Description
    The Jostra Vent Catheters are sterile devices for single use only and are not to be resterilized by the user. They are designed for use in venting the left ventricle during cardiopulmonary bypass surgery. The catheter is inserted into the left ventricle via the pulmonary vein, cardiac auricle or cardiac apex. The catheters are made of polyvinyl chloride and are available in a variety of sizes. They are also available in a variety of configurations (straight or bent tip, with or without wire reinforcement, with or without an integrated stylet, with or without a vacuum valve, malleable and non malleable). The catheters range from 8 to 18 French and are offered in lengths from 23 to 40 cm.
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    K Number
    K020515
    Device Name
    JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
    Manufacturer
    JOSTRA AG
    Date Cleared
    2002-04-24

    (68 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Antegrade Cardioplegia Cannulas are intended to be used to infuse blood and/or cardioplegia solution to the patient's myocardium, antegrade, via the aortic root, during cardiopulmonary bypass for 6 hours or less.
    Device Description
    The Jostra Antegrade Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia solution antegrade via the aortic root during extracorporeal circulation. The cannulas are made from polyurethane (PUR) in sizes 7 Fr., 9Fr., and 11 Fr., with or without vent lines and with an optional needle safety system.
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    K Number
    K014303
    Device Name
    JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
    Manufacturer
    JOSTRA AG
    Date Cleared
    2002-03-26

    (85 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Retrograde Cardioplegia Cannulas are designed to infuse blood or cardioplegia arrest solution to the myocardial tissue retrograde via the coronary sinus during cardiopulmonary bypass up to 6 hours or less.
    Device Description
    The Jostra Retrograde Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia arrest solution retrograde via the coronary sinus during extracorporeal circulation. The cannulas are made from polyvinyl chloride (PVC) in size 14 Fr. with a variety of balloons, with or without pressure monitoring lines and a choice of stiff or flexible stylets.
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    K Number
    K013944
    Device Name
    JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
    Manufacturer
    JOSTRA AG
    Date Cleared
    2002-02-11

    (74 days)

    Product Code
    DWF, DTL
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Two-Stage Venous Cannulas are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.
    Device Description
    The Jostra Two-Stage Venous Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to divert blood from the patient to the extracorporeal circuit by draining blood simultaneously from the Right atrium and the Inferior vena cava. The cannulae are made from polyvinyl chloride (PVC) and range in size from 32Fr./40Fr. to 36Fr./51Fr. with a variety of tips and with or without attached connectors.
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    K Number
    K013939
    Device Name
    JOSTRA FLOWPROBE FP-32E
    Manufacturer
    JOSTRA AG
    Date Cleared
    2001-12-14

    (15 days)

    Product Code
    DPT
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Flowprobe FP-32E is indicated for use as a flow measuring device to be used as an electromagnetic blood flow transducer as a direct product replacement for the BioMedicus flowprobe DP-38 in extracorporeal circuits for up to 6 hours.
    Device Description
    The Jostra Flowprobe FP-32E is a single, sterile device for single use only and not to be re-sterilized by the user. The flowprobe is made from polycarbonate and is available in a 3/8" size.
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    K Number
    K012774
    Device Name
    JOSTRA ARTERIAL PERFUSION CANNULAE
    Manufacturer
    JOSTRA AG
    Date Cleared
    2001-11-16

    (88 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOSTRA AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass up to 6 hours or less.
    Device Description
    The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.
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