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

    NFC NEEDLEFREE Y-SITE, MODEL 69970

    K Number: K981547 · Decision Jun 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    10
    Review Days
    49

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    Basic Information

    Device Name
    NFC NEEDLEFREE Y-SITE, MODEL 69970
    K Number
    K981547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Filtertek, Inc.
    Date Received
    April 30, 1998
    Decision Date
    June 18, 1998
    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 Filtertek, Inc.

    K Number Device Name
    K981548 NFC NEEDLEFREE CONNECTOR MODEL 69900
    K914792 PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET
    K912848 I.V. FILTER EXTENSION SET
    K912394 TRANSDUCER PROTECTOR
    K911451 I.V. EXTENDER SET
    K904912 TRANSDUCER PROTECTOR
    K901409 TRANSDUCER PROTECTOR
    K901996 FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR
    K895281 TRANSDUCER PROTECTOR