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

    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER

    K Number: K091214 · Decision Sep 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    17
    Same Product Code
    33
    Applicant Total
    6
    Review Days
    151

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    Basic Information

    Device Name
    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
    K Number
    K091214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Footprint Medical
    Date Received
    April 27, 2009
    Decision Date
    September 25, 2009
    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

    K Number Device Name
    K093026 FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
    K091213 FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
    K091488 FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C
    K090576 FOOTPRINT URINARY DRAINAGE CATHETER
    K090559 FOOTPRINT MEDICAL SILICONE FEEDING TUBE