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510(k) Data Aggregation

    K Number
    K983802
    Device Name
    LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
    Manufacturer
    LUCAS MEDICAL, INC.
    Date Cleared
    1999-07-30

    (275 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUCAS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LMI Carotid Endarterectomy Shunt Catheter is intended for use during a carotid endarterectomy procedure to provide temporary carotid artery bypass (blood flow) for cerebral circulation.
    Device Description
    The LMI Carotid Endarterectory Shunt Catheter consists of a multi-lumen, straight or tapered silicone tube with or without stainless steel wire reinforcement with one or more silicone balloons formed at either or both ends. Additional silicone tubes are attached at the approximate center and at approximately 90 degrees of the main tube for communicaton with the main central lumen as well as the smaller lumen used to inflate the balloons that are located on either or both ends. The proximal ends of the balloon inflation tubes are fitted with a female luer connector and may on some models incorporate a strain relief that is bonded to the silicone shaft. The proximal communicating tube is also fitted with a female luer connector and models incorporate a strain relief that is bonded to the silicone shaft. Stopcocks are attached to the female her connecting tubes. The ends of the main nulti-lumen tube are end formed to create a soft leading edge. The main multi-lumen tube may also be tapered in certain models to enchance blood tlow.
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    K Number
    K972623
    Device Name
    LMI IRRIGATION CATHETER (IGR)
    Manufacturer
    LUCAS MEDICAL, INC.
    Date Cleared
    1997-11-19

    (128 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUCAS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LMI Irrigation Catheter is intended for intra-operative procedures requiring irrigation in either arterial or venous blood vessels.
    Device Description
    The catheter consists of a stainless steel wire reinforced silicone tube that is end formed to create a rounded leading nose. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The distal end of the catheter has four side ports as well as central lumens that provide openings for irrigating fluid. The "DEVICE" is packaged in an ElO breathable tray for protection and then sealed in an EtO breathable pouch. It is E.O sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only and is used only By or On the Order of a Physician.
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    K Number
    K970657
    Device Name
    LMI THROMBECTOMY CATHETER
    Manufacturer
    LUCAS MEDICAL, INC.
    Date Cleared
    1997-07-01

    (130 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUCAS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LMI Thrombectomy Catheter is intended for use in venous thrombectomy procedures for intra-operative removal of venous thrombus formations from veins.
    Device Description
    Not Found
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    K Number
    K955126
    Device Name
    LMI BILIARY CATHETER
    Manufacturer
    LUCAS MEDICAL, INC.
    Date Cleared
    1996-05-10

    (183 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUCAS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for intra-operative short term use in the biliary tree to aid in the removal of ductal stones and debris.
    Device Description
    The catheter consists of a single lumen stainless steel wire reinforced silicone lube that is end formed to create a rounded leading nose. A silicone balloon is bonded to the cather at the end form. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The "DEVICE" is packaged in an ErO breathable tray for protection and then sealed in an ErO breathable pouch. It is EtO sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only By or On the Order of a Physician.
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    K Number
    K954760
    Device Name
    LMI ARTERIAL EMBOLECTOMY CATHETER
    Manufacturer
    LUCAS MEDICAL, INC.
    Date Cleared
    1996-04-11

    (177 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUCAS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955125
    Device Name
    LMI OCCLUSION CATHETER
    Manufacturer
    LUCAS MEDICAL, INC.
    Date Cleared
    1996-03-11

    (123 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUCAS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955499
    Device Name
    LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER
    Manufacturer
    LUCAS MEDICAL, INC.
    Date Cleared
    1996-02-28

    (89 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUCAS MEDICAL, INC.

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