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

    ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN

    K Number: K083763 · Decision Mar 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    7
    Review Days
    88

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    Basic Information

    Device Name
    ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
    K Number
    K083763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R4 Vascular, Inc.
    Date Received
    December 18, 2008
    Decision Date
    March 16, 2009
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by R4 Vascular, Inc.

    K Number Device Name
    K131329 VECTOR PTA BALLOON DILATATION CATHETER
    K121385 VECTOR
    K100169 DURASPAN HEMODIALYSIS LONG-TERM CATHETER
    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
    K071361 R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005