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

    INTRAVASCULAR ADMINISTRATION SET

    K Number: K945184 · Decision Feb 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    8
    Review Days
    107

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    Basic Information

    Device Name
    INTRAVASCULAR ADMINISTRATION SET
    K Number
    K945184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Distronic Sterile Products, Inc.
    Date Received
    October 24, 1994
    Decision Date
    February 8, 1995
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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    Other Clearances by Distronic Sterile Products, Inc.

    K Number Device Name
    K955732 VENTED SOLUTION SET
    K955709 WINGED & SUBCUTANEOUS INFUSION SETS
    K954984 MINIBORE STOPCOCK SET
    K954983 EXTENSION SET WITH CHECK VALVE
    K952664 SOLUTION ADMINISTRATION SET
    K950597 CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE
    K952663 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP