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

    CS MEDICAL ADULT TTCF CATHETER

    K Number: K050379 · Decision Jul 12, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    2
    Review Days
    147

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    Basic Information

    Device Name
    CS MEDICAL ADULT TTCF CATHETER
    K Number
    K050379
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cs Medical, Inc.
    Date Received
    February 15, 2005
    Decision Date
    July 12, 2005
    Product Code
    BTO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Cs Medical, Inc.

    K Number Device Name
    K050381 CS MEDICAL TTCF GAS DELIVERY SYSTEM