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

    DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520

    K Number: K091506 · Decision Jan 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    7
    Review Days
    232

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    Basic Information

    Device Name
    DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
    K Number
    K091506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    R4 Vascular, Inc.
    Date Received
    May 21, 2009
    Decision Date
    January 8, 2010
    Product Code
    MSD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MSD Catheter, Hemodialysis, Implanted

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    Other Clearances by R4 Vascular, Inc.

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    K083763 ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
    K071361 R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005