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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
    K093026
    Device Name
    FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2010-02-24

    (148 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOOTPRINT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to facilitate placing a catheter through the skin into a vein or artery.
    Device Description
    Not Found
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    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
    K Number
    K091213
    Device Name
    FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-09-25

    (151 days)

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

    FOOTPRINT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.
    Device Description
    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, DUAL LUMEN.
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    K Number
    K091214
    Device Name
    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-09-25

    (151 days)

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

    FOOTPRINT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS CATHETER IS FOR USE IN NEWBORN PEDIATRIC OR NEONATAL PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE AND ADMINISTER I.V.FLUIDS THROUGH AN UMBILICAL VESSEL.
    Device Description
    Not Found
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    K Number
    K091488
    Device Name
    FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-09-14

    (118 days)

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

    FOOTPRINT MEDICAL

    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
    Peripherally Inserted Central Catheter
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    K Number
    K090576
    Device Name
    FOOTPRINT URINARY DRAINAGE CATHETER
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-08-12

    (162 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOOTPRINT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Footprint Urinary Drainage Catheter is a flexible tube intended for drainage of urine from small pediatric or Neonatal patients. This is a prescription device intended for use for less than 30 days. It is not implanted and is not a life supporting device.
    Device Description
    Not Found
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    K Number
    K090559
    Device Name
    FOOTPRINT MEDICAL SILICONE FEEDING TUBE
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-05-04

    (63 days)

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

    FOOTPRINT MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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