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

    PARSET, MODEL A10001E

    K Number: K992104 · Decision Aug 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    4
    Review Days
    62

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    Basic Information

    Device Name
    PARSET, MODEL A10001E
    K Number
    K992104
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rd Medical Mfg., Inc.
    Date Received
    June 22, 1999
    Decision Date
    August 23, 1999
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by Rd Medical Mfg., Inc.

    K Number Device Name
    K010538 PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E
    K001102 PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
    K000017 PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400