BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter

    K Number: K200027 · Decision Sep 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    15
    Review Days
    247

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    Basic Information

    Device Name
    Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
    K Number
    K200027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Caina Medical Co.,Ltd
    Date Received
    January 6, 2020
    Decision Date
    September 9, 2020
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Jiangsu Caina Medical Co.,Ltd

    K Number Device Name
    K232781 Safety Sliding Blood Collection Set
    K233190 ENFit Adaptor
    K230635 Pen Needle
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    K211593 Enteral Pump Syringe
    K210217 Needleless Connector
    K200463 Huber Needle Infusion Set, Safety Huber Needle Infusion Set
    K201356 Plastic LOR Syringe
    K193022 Retractable Safety Insulin Syringe
    K193526 Syringe with safety needle, Safety needle
    Search all 15 clearances from Jiangsu Caina Medical Co.,Ltd →