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

    DUAL LUMEN CATHETER (DLC) TRAY

    K Number: K941851 · Decision Mar 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    4
    Review Days
    333

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    Basic Information

    Device Name
    DUAL LUMEN CATHETER (DLC) TRAY
    K Number
    K941851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neostar Medical Technologies, Inc.
    Date Received
    April 14, 1994
    Decision Date
    March 13, 1995
    Product Code
    KOC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOC Accessories, Blood Circuit, Hemodialysis

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    Other Clearances by Neostar Medical Technologies, Inc.

    K Number Device Name
    K960625 SPREADABLE SHEATH INTRODUCER SET
    K944660 ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY
    K944511 ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)