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

    NIPRO SAFETOUCH HUBER INFUSTION SET

    K Number: K081210 · Decision Oct 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    27
    Review Days
    175

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    Basic Information

    Device Name
    NIPRO SAFETOUCH HUBER INFUSTION SET
    K Number
    K081210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nipro Medical Corp.
    Date Received
    April 29, 2008
    Decision Date
    October 21, 2008
    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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    K063721 NIPRO SAFETOUCH II GAMMA
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    K051574 NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
    K041779 NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
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    K030683 NIPRO DISPOSABLE SYRINGES
    K022756 NIPRO BIO-FLEX CATHETER
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