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510(k) Data Aggregation

    K Number
    K980957
    Device Name
    KAPLAN-SIMPSON INFUSASLEEVE II
    Manufacturer
    LOCALMED, INC.
    Date Cleared
    1998-06-10

    (86 days)

    Product Code
    QEY, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOCALMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InfusaSleeve II is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion.
    Device Description
    The Kaplan-Simpson InfusaSleeve™ II is a multi-lumen catheter consisting of a proximal infusion port, a proximal shaft, and a main catheter shaft which is proximal to the infusion region. An entry port for balloon and guide wire is selected with a distal infusion region. The infusion region consists of four separate infusion lumens each with multiple sideholes. Radiopaque markers are located within the infusion region. Infusion solution is delivered through the proximal infusion port, through the four infusion lumens and exits through the sideholes into the coronary vasculature. A standard luer adapter allows for attachment of a syringe with a manometer or equivalent to the proximal infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve II is designed to track over standard dilatation catheters.
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    K Number
    K972175
    Device Name
    INFUSASLEEVE IIA (IS-2A)
    Manufacturer
    LOCALMED, INC.
    Date Cleared
    1997-08-28

    (80 days)

    Product Code
    QEY, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOCALMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InfusaSleeve IIa is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion.
    Device Description
    The Kaplan-Simpson InfusaSleeve™ IIa is a multi-lumen catheter consisting of a proximal infusion port, a proximal shaft, and a main catheter shaft with a distal infusion region. An entry port for balloon and guide wire access is located at the proximal end of the main shaft which is proximal to the infusion region. The infusion region consists of four separate infusion lumens each with multiple sideholes. Radiopaque markers are located within the infusion region. Infusion solution is delivered through the proximal infusion port, through the four infusion lumens and exits through the sideholes into the coronary vasculature. A standard luer adapter allows for attachment of a syringe with a manometer or equival infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve IIa is designed to track over standard dilatation catheters.
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