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

    EXTENSION SET WITH CHECK VALVE

    K Number: K954983 · Decision Jan 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    8
    Review Days
    84

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    Basic Information

    Device Name
    EXTENSION SET WITH CHECK VALVE
    K Number
    K954983
    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 31, 1995
    Decision Date
    January 23, 1996
    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 Distronic Sterile Products, Inc.

    K Number Device Name
    K955732 VENTED SOLUTION SET
    K955709 WINGED & SUBCUTANEOUS INFUSION SETS
    K954984 MINIBORE STOPCOCK SET
    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
    K945184 INTRAVASCULAR ADMINISTRATION SET