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

    FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER

    K Number: K120304 · Decision Mar 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    17
    Same Product Code
    33
    Applicant Total
    4
    Review Days
    29

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    Basic Information

    Device Name
    FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
    K Number
    K120304
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Footprint Medical, Inc.
    Date Received
    February 1, 2012
    Decision Date
    March 1, 2012
    Product Code
    FOS
    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
    FOS Catheter, Umbilical Artery

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    Other Clearances by Footprint Medical, Inc.

    K Number Device Name
    K130507 FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
    K102548 FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE
    K093252 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER