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510(k) Data Aggregation

    K Number
    K130507
    Device Name
    FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Date Cleared
    2013-06-03

    (96 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOOTPRINT MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: Medications, TPN nutritional solutions, and Intravenous infusion of fluids are needed.
    Device Description
    Not Found
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    K Number
    K120304
    Device Name
    FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Date Cleared
    2012-03-01

    (29 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOOTPRINT MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.
    Device Description
    FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
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    K Number
    K102548
    Device Name
    FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Date Cleared
    2010-11-26

    (84 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOOTPRINT MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K093252
    Device Name
    FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Date Cleared
    2009-12-17

    (62 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOOTPRINT MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: medications, TPN nutritional solutions, and intravenous infusion of fluids are needed.
    Device Description
    Not Found
    Ask a Question

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