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

    ACTI-FLEX IV ADMINISTRATION SET

    K Number: K001599 · Decision Sep 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    117

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    Basic Information

    Device Name
    ACTI-FLEX IV ADMINISTRATION SET
    K Number
    K001599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    R-Group Intl.
    Date Received
    May 24, 2000
    Decision Date
    September 18, 2000
    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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    K952470 ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
    K954035 ACTI-FLEX ARTERIAL EXTENSION SET
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    K913267 R-GROUP INTL. ONE WALL PUNCTURE NEEDLE