Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K223499
    Device Name
    Three Way Stop Cock
    Manufacturer
    M/s Romsons International
    Date Cleared
    2023-07-21

    (242 days)

    Product Code
    FMG
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    M/s Romsons International

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3-way stopcocks are indicated for venous or arterial use, as IV add-on devices used for simultaneous infusions. intermittent drug injections, for central venous pressure measurements, and as arterial add-on devices used for invasive pressure measurements, flushing with normal saline.
    Device Description
    Three Way Stop cock is composed of a Body, Rotating Handle, Luer Ports – with 2 female luer lock & 1 male luer lock with Rotating Nut. Compatible with 6% Luer combination devices. Transparent, lipid resistant body, provides easy visualization, and indicates fluid path. The device is designed and tested as per its device specific guidance: "Intravascular Administration Sets Premarket Notification Submissions [510(k)]". 3- Way Stop Cock is used for pressure infusion, for selective running of one or two paths intravenous lines & for measurement & also for monitoring of central venous pressure. 3- Way Stop Cock lipid-resistant is for infusing lipid-fluids & other intravenous fluids. Maximum use duration of the device is not beyond 5 days.
    Ask a Question

    Page 1 of 1