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

    DURASPAN HEMODIALYSIS LONG-TERM CATHETER

    K Number: K100169 · Decision Feb 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    DURASPAN HEMODIALYSIS LONG-TERM CATHETER
    K Number
    K100169
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    R4 Vascular, Inc.
    Date Received
    January 20, 2010
    Decision Date
    February 18, 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.

    K Number Device Name
    K131329 VECTOR PTA BALLOON DILATATION CATHETER
    K121385 VECTOR
    K091506 DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
    K092040 PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240
    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