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

    VIAL2BAG DIRECT CONNECT

    K Number: K140730 · Decision Jun 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    176
    Registration Numbers
    176
    Same Product Code
    200
    Applicant Total
    11
    Review Days
    80

    Basic Information

    Device Name
    VIAL2BAG DIRECT CONNECT
    K Number
    K140730
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDIMOP MEDICAL PROJECTS, LTD.
    Date Received
    March 24, 2014
    Decision Date
    June 12, 2014
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by MEDIMOP MEDICAL PROJECTS, LTD.

    K Number Device Name
    K130179 MP VIAL ADAPTER 13MM
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    K122023 MIXJECT WITH SPRAY HEAD
    K072511 SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM
    K072759 VIAL2BAG
    K062482 VENTED VIAL ADAPTER TRANSFER DEVICE
    K031861 MIX2VIAL TRANSFER DEVICE
    K001831 NEEDLELESS TRANSFER DEVICE
    K001293 MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
    K963583 MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE
    Search all 11 clearances from MEDIMOP MEDICAL PROJECTS, LTD. →