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510(k) Data Aggregation

    K Number
    K972814
    Device Name
    LOCATOR MODEL 4036
    Manufacturer
    PACESETTER, INC.
    Date Cleared
    1998-02-23

    (209 days)

    Product Code
    DTB
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACESETTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Locator™ Steerable Stylet is intended for use when implanting the Pacesetter Tendril® model 1188 T/K pacemaker leads, in 46, 52, and 58 cm lengths in patients requiring long-term lead implantation to provide cardiuc pacing.
    Device Description
    The Locator™ steerable stylet consists of a curved wire that fits inside a thin-walled tube. Sliding the tube relative to the wire by manipulating the handle allows different curvatures on the stylet, and thus the lead, to be obtained.
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    K Number
    K960854
    Device Name
    SIEMENS SERVO ULTRA NEBULIZER 345
    Manufacturer
    PACESETTER, INC.
    Date Cleared
    1996-12-23

    (297 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACESETTER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Siemens Model 345 Ultra Nebulizer is to nebulize liquid medication for introduction into the patient's airway via an endotracheal tube. It can be used on any patient for whom the use of the Siemens Servo Ventilator 300 is indicated, in any ventilatory mode appropriate for the patient.
    Device Description
    The Servo Ultra Nebulizer 345 (SUN 345) is an accessory to the Servo Ventilator 300 that is used to nebulize medication during ventilator treatment. An ultrasonic nebulizer similar to those commonly marketed as a component of home "medication inhaler" devices has been adapted for use in the patient circuit of the Servo Ventilator. The ultrasonic nebulizer does not add any gas volume to the circuit, so that readings and settings on the ventilator are unaffected. The SUN 345 medication cup holds 10 ml of liquid, which is nebulized at a rate of 0.3 ml/min at 0.5 1/min gas flow. The mass median diameter of particles is 4.0 um.
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    K Number
    K954714
    Device Name
    AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
    Manufacturer
    PACESETTER, INC.
    Date Cleared
    1996-02-01

    (122 days)

    Product Code
    DTB
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACESETTER, INC.

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