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

    BD PosiFlush Heparin Lock Flush Syringe

    K Number: K163591 · Decision Feb 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    6
    Applicant Total
    134
    Review Days
    69

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    Basic Information

    Device Name
    BD PosiFlush Heparin Lock Flush Syringe
    K Number
    K163591
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    December 20, 2016
    Decision Date
    February 27, 2017
    Product Code
    NZW
    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
    NZW Heparin, Vascular Access Flush

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NZW), ordered by most recent decision date.

    HEPARIN LOCK / FLUSH SYRINGES

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    HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710

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    FDA Class 2 ·General Hospital

    MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML

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    FDA Class 2 ·General Hospital

    SYREX PRE-FILLED SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital
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