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510(k) Data Aggregation

    K Number
    K000767
    Device Name
    MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
    Manufacturer
    MEMCATH TECHNOLOGIES LLC.
    Date Cleared
    2000-06-05

    (88 days)

    Product Code
    KNY
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEMCATH TECHNOLOGIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993226
    Device Name
    MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
    Manufacturer
    MEMCATH TECHNOLOGIES LLC.
    Date Cleared
    1999-12-10

    (74 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEMCATH TECHNOLOGIES LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.
    Device Description
    The Memcath Urology Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a PVC catheter tube with pre-loaded, self-deploying PTFE sheath membrane to increase lubricity during insertion. This catheter system also includes a polyurethane snap ring and polycarbonate/acrylic guide ring to secure the sheath.
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