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Found 8 results

510(k) Data Aggregation

    K Number
    K001621
    Device Name
    DARDIK CAROTID SHUNT
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-12-06

    (194 days)

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

    VASCUTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992942
    Device Name
    LEMAITRE OCCLUSION CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-04-13

    (226 days)

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

    VASCUTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMaitre Occlusion Catheter is indicated for temporary vessel occlusion.
    Device Description
    Not Found
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    K Number
    K992933
    Device Name
    LEMAITRE IRRIGATION CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-03-08

    (190 days)

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

    VASCUTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMaitre Irrigation Catheters are used to irrigate arteries after thrombo-embolectomy, veins after thrombectomy, and the biliary tree after intraductal stone removal.
    Device Description
    Not Found
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    K Number
    K992934
    Device Name
    LEMAITRE VENOUS THROMBECTOMY CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-03-01

    (183 days)

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

    VASCUTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMaitre Venous Thrombectomy Catheter is indicated for the removal of venous thrombi.
    Device Description
    Not Found
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    K Number
    K992940
    Device Name
    LEMAITRE BALLOON CATHETER WITH IRRIGATION
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-02-22

    (175 days)

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

    VASCUTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMaitre Balloon Catheter with Irrigation is indicated for the extraction of emboli and thrombi from the peripheral arterial system and also may be used for infusion of fluids.
    Device Description
    Not Found
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    K Number
    K992941
    Device Name
    LEMAITRE BILIARY CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    2000-01-12

    (134 days)

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

    VASCUTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMaitre Biliary Catheter is indicated for the removal of stones and ductal debris.
    Device Description
    Not Found
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    K Number
    K992368
    Device Name
    LEMAITRE EMBOLECTOMY CATHETER
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    1999-12-09

    (147 days)

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

    VASCUTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMaitre Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi.
    Device Description
    Not Found
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    K Number
    K980723
    Device Name
    2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
    Manufacturer
    VASCUTECH, INC.
    Date Cleared
    1999-02-12

    (353 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCUTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cuts saphenous vein valves during in situ bypass procedure in lower extremities.
    Device Description
    Not Found
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