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

    #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK

    K Number: K870324 · Decision Mar 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    10
    Review Days
    44

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
    K Number
    K870324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Clinical Connections, Inc.
    Date Received
    January 28, 1987
    Decision Date
    March 13, 1987
    Product Code
    FMG
    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
    FMG Stopcock, I.V. Set

    Similar 510(k) Clearances

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

    Qitexio® 4-Way Stopcock (QIT014)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Three Way Stop Cock

    FDA 510(k)
    FDA Class 2 ·General Hospital

    lntravascular Administration Sets with Stopcock and Manifold

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SafePort(TM) Manifold (or Stopcock)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Clicky Cross

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Clinical Connections, Inc.

    K Number Device Name
    K884435 RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
    K871540 SWIVEL CONNECTORS #014452/#014453/#014459-120
    K870325 #014160-TAB TUBING ROTATOR ADAPTOR
    K870477 DEVICE CONNECTORS #000299-000 3/8 X 3/8 X 3/8 Y
    K870913 INJECTION SITE #014456-120
    K870912 T-CONNECTORS 014500/014501/014502/014503-120
    K870394 HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
    K870073 MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
    K870326 VARIOUS LUER AND TUBING FITTINGS