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510(k) Data Aggregation

    K Number
    K152934
    Device Name
    MMS PTA Balloon Catheter
    Manufacturer
    MicroMedical Solutions, Inc.
    Date Cleared
    2016-04-25

    (203 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroMedical Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Medical Solutions PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including anterior tibial, posterior tibial, and pedal. Not for use in coronary arteries.
    Device Description
    The Micro Medical Solutions PTA Balloon Catheter is a single lumen catheter with a balloon located at the distal tip. As the MMS PTA Balloon Catheter is not an Over-The-Wire device. The catheter consists of a single lumen for balloon inflation and deflation.. Inscribed on the proximal strain relief of the catheter is the balloon diameter (mm) and balloon length (mm). Platinum/Iridium marker bands are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy.
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    K Number
    K152625
    Device Name
    MMS Guide Catheter
    Manufacturer
    MicroMedical Solutions, Inc.
    Date Cleared
    2016-03-09

    (176 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroMedical Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.
    Device Description
    The MMS Guide Catheter is a small diameter tubular device. It is inserted into the vasculature using standard access techniques and advanced over a guidewire to the physician desired location. The MMS Guide Catheter can be used as a pathway for other diagnostic or therapeutic devices to enter the vasculature. The distal end has a standard luer fitting.
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