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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE

    K Number: K141306 · Decision Jun 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    4
    Review Days
    24

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    Basic Information

    Device Name
    TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE
    K Number
    K141306
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teva Medical Ltd., Migada Plant
    Date Received
    May 19, 2014
    Decision Date
    June 12, 2014
    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 Teva Medical Ltd., Migada Plant

    K Number Device Name
    K180489 TEVADAPTOR Closed Drug Reconstitution and Transfer System
    K170680 TEVADAPTOR Closed Drug Reconstitution and Transfer System
    K141448 TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM