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510(k) Data Aggregation

    K Number
    K003889
    Device Name
    ANCURE SHEATH MODEL # 40315, 40320, 40325
    Manufacturer
    GUIDANT CARDIAC AND VASCULAR SURGERY
    Date Cleared
    2002-01-24

    (402 days)

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

    GUIDANT CARDIAC AND VASCULAR SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001694
    Device Name
    GUIDANT RETRIEVER DEVICE
    Manufacturer
    GUIDANT CARDIAC AND VASCULAR SURGERY
    Date Cleared
    2001-05-15

    (347 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CARDIAC AND VASCULAR SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003495
    Device Name
    ANCURE LLIAC BALLOON CATHETER
    Manufacturer
    GUIDANT CARDIAC AND VASCULAR SURGERY
    Date Cleared
    2001-02-07

    (86 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CARDIAC AND VASCULAR SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002676
    Device Name
    ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER
    Manufacturer
    GUIDANT CARDIAC AND VASCULAR SURGERY
    Date Cleared
    2000-10-30

    (63 days)

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

    GUIDANT CARDIAC AND VASCULAR SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K970470
    Device Name
    EVT EXPANDABLE SHEATH
    Manufacturer
    GUIDANT CARDIAC AND VASCULAR SURGERY
    Date Cleared
    1997-07-31

    (174 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CARDIAC AND VASCULAR SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K970469
    Device Name
    EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
    Manufacturer
    GUIDANT CARDIAC AND VASCULAR SURGERY
    Date Cleared
    1997-05-08

    (90 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CARDIAC AND VASCULAR SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EVT AngioScale angiography catheters provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.
    Device Description
    The EVT AngioScale angiography catheter is a PEBAX pigtail catheter with 11 to 20 radiopaque platinum marker bands on the catheter tubing. This 6 - 7 French catheter rides over a .038" guide wire. A standard polycarbonate luer adapter at the proximal end allows for injection of contrast media. Distal ports disperse the contrast media for angiographic visualization. The EVT AngioScale angiography catheter has multiple radiopaque platinum marker bands so that the entire length of the marked catheter image can be used as a scaled ruler. The EVT AngioScale angiography catheter is provided sterile to the end user. It is disposable, with a useable life of one procedure.
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    K Number
    K970608
    Device Name
    EVT MARKER BOARD
    Manufacturer
    GUIDANT CARDIAC AND VASCULAR SURGERY
    Date Cleared
    1997-04-21

    (62 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUIDANT CARDIAC AND VASCULAR SURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures.
    Device Description
    The EVT® Marker Board is an all-mechanical aid placed external to the body. It consists of two main components, 1) the polycarbonate plate which houses the radiopaque, movable markers, and 2) the control box which is used to remotely move the position of the markers.
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