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

    FOOTPRINT URINARY DRAINAGE CATHETER

    K Number: K090576 · Decision Aug 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    81
    Applicant Total
    6
    Review Days
    162

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    Basic Information

    Device Name
    FOOTPRINT URINARY DRAINAGE CATHETER
    K Number
    K090576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Footprint Medical
    Date Received
    March 3, 2009
    Decision Date
    August 12, 2009
    Product Code
    EZD
    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
    EZD Catheter, Straight

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    Other Clearances by Footprint Medical

    K Number Device Name
    K093026 FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
    K091213 FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
    K091214 FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
    K091488 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C
    K090559 FOOTPRINT MEDICAL SILICONE FEEDING TUBE