BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    TEVADAPTOR Closed Drug Reconstitution and Transfer System

    K Number: K180489 · Decision Sep 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    4
    Review Days
    210

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    Basic Information

    Device Name
    TEVADAPTOR Closed Drug Reconstitution and Transfer System
    K Number
    K180489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teva Medical Ltd., Migada Plant
    Date Received
    February 23, 2018
    Decision Date
    September 21, 2018
    Product Code
    ONB
    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
    ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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    Other Clearances by Teva Medical Ltd., Migada Plant

    K Number Device Name
    K170680 TEVADAPTOR Closed Drug Reconstitution and Transfer System
    K141448 TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
    K141306 TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE