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

    NEXUS PRESSURE RATED EXTENSION SETS

    K Number: K092382 · Decision Apr 26, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    16
    Review Days
    264

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    Basic Information

    Device Name
    NEXUS PRESSURE RATED EXTENSION SETS
    K Number
    K092382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nexus Medical, LLC
    Date Received
    August 5, 2009
    Decision Date
    April 26, 2010
    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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    K092930 NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
    K092527 NEXUS INJECTION SITE, MODEL NIS-8
    K081123 NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS
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