BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE

    K Number: K875213 · Decision Mar 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    3
    Review Days
    76

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    Basic Information

    Device Name
    SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE
    K Number
    K875213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Titan Medical, Inc.
    Date Received
    December 18, 1987
    Decision Date
    March 3, 1988
    Product Code
    LJT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Titan Medical, Inc.

    K Number Device Name
    K872149 SURECATH-ITP PERCUTANEOUS ACCESS KIT
    K870542 VASCATH VASCULAR CATHETER PLACEMENT KIT