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

    HEPARIN LOCK / FLUSH SYRINGES

    K Number: K133446 · Decision Nov 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    367

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    Basic Information

    Device Name
    HEPARIN LOCK / FLUSH SYRINGES
    K Number
    K133446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excelsior Medical Corporation
    Date Received
    November 12, 2013
    Decision Date
    November 14, 2014
    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

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

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    SYREX PRE-FILLED SYRINGE

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    Other Clearances by Excelsior Medical Corporation

    K Number Device Name
    K142620 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe