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510(k) Data Aggregation

    K Number
    K021916
    Device Name
    HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-08-29

    (79 days)

    Product Code
    FPA, FMI, LJT
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARMAC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is for the removal of 90 degree winged infusion sets, manufactured by Harmac Medical Products and having a 1-1/2" needle or shorter, from implanted ports and the containment of the used needle until placed in an appropriate sharps container. When used in this manner this device is intended to aid in the prevention of needle stick injuries.
    Device Description
    The Harmac Medical Huber Needle Safety Device is designed as an accessory to Harmac Huber Needle Infusion Sets to assist in the removal and containment of ninety-degree Huber needles from implanted IV ports. The device consists of a single injection molded plastic component incorporating a stabilizing foot and an internal design to capture the proprietary needle hub of the Harmac Medical Infusion Set as it is slid up a receiving slot in one side. Only one version of the device will be marketed and will accommodate a range of Harmac Huber needles up to 19 gauge, 1-1/2" in length. The Huber Needle Safety Device is used by placing the open slot over the hub of the Harmac Infusion Set needle and using the foot of the device to stabilize the patient's skin via downward pressure with one hand. The other hand is used to grasp the wings of the Huber needle and draw it upward into the Safety Device. As the Huber needle reaches the top of the device the proprietary head locks into place. As the needle is drawn upwards it is also turned slightly to the side to keep the needle from protruding through the receiving slot. This method of operation requires two hands but eliminates the rebound reflex by locking the needle hub and keeping the other hand behind the device at all times. The Huber Needle Safety Device is provided as a sterile accessory packaged only with Harmac Infusion Sets. It is provided as a disposable, single use device.
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    K Number
    K962829
    Device Name
    HARMAC BALLOON ANGIOGRAPHIC CATHETER
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-16

    (475 days)

    Product Code
    DQO, DOO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARMAC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Balloon Angiographic catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be used to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart.
    Device Description
    Harmac Balloon Angiographic Catheter
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    K Number
    K963335
    Device Name
    HARMAC BALLOON WEDGE PRESSURE CATHETER
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-16

    (475 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARMAC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Balloon Wedge Pressure catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure and pulmonary artery wedge pressure). In the case of anatomical cardiac defect or situations requiring left transseptal access, this catheter may be used in any chamber which can be entered from the right heart.
    Device Description
    Harmac Balloon Wedge Pressure Catheter
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    K Number
    K962833
    Device Name
    HARMAC TEMPORARY PACING CATHETER WITH BALLOON
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-10-15

    (474 days)

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

    HARMAC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Balloon Temporary Pacing catheter is indicated for use in temporary transvenous ventricular cardiac pacing when impulse formation or conduction is impaired.
    Device Description
    Harmac Temporary Pacing Catheter with Balloon
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    K Number
    K963073
    Device Name
    HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-08-14

    (412 days)

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

    HARMAC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired.
    Device Description
    Harmac Temporary Pacing Catheter with Stylet
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    K Number
    K963336
    Device Name
    HARMAC THERMODILUTION CATHETER
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-08-14

    (412 days)

    Product Code
    DYG
    Regulation Number
    870.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARMAC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Balloon Thermodilution catheter is indicated for use in measuring cardiac output by the thermodilution method. In addition, this balloon thermodilution catheter can be used to measure right atrial pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary capillary wedge pressure.
    Device Description
    Harmac Thermodilution Catheter
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    K Number
    K963074
    Device Name
    HARMAC QUADPOLAR MAPPING PACING CATHETER
    Manufacturer
    HARMAC MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-06-25

    (362 days)

    Product Code
    DRF, 74D
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    HARMAC MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mapping of electrical signals of the His bundle and also used to stimulate the myocardium to depolarize at a rate higher than the intrinsic heart rate or at a rate sufficient to maintain adequate cardiac output until definitive treatment can be instituted.
    Device Description
    Harmac Quadpolar MappingPacing Catheter with Stylet
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