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510(k) Data Aggregation

    K Number
    K022272
    Device Name
    MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS
    Date Cleared
    2003-01-08

    (177 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.
    Device Description
    The Medtronic DLP Malleable Single Stage Venous Cannulae represent modified versions of existing Medtronic Single Stage Venous Cannulae. The proposed change involves the incorporation of a malleable wire/tube assembly embedded within the wall of the cannula. This malleable wire/tube assembly allows the cannula body to be shaped into a surgeon preferred position.
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    K Number
    K013013
    Device Name
    MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS
    Date Cleared
    2001-12-04

    (88 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These cannulae are intended for the perfusion of the ascending aorta during short-term (6 hours or less) cardiopulmonary bypass.
    Device Description
    The Medtronic DLP Arterial Cannulae with 3D Tip represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. cannula. This baffled tip imparts a more diffuse pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.
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    K Number
    K012143
    Device Name
    24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS
    Date Cleared
    2001-10-24

    (106 days)

    Product Code
    DRA
    Regulation Number
    870.1280
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.
    Device Description
    The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the left heart during cardiopulmonary bypass surgery. The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is equipped with a pressure monitoring line, which allows measurement of left ventricular pressure.
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    K Number
    K010737
    Device Name
    SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS
    Date Cleared
    2001-04-04

    (23 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000776
    Device Name
    MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS
    Date Cleared
    2001-02-07

    (334 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994171
    Device Name
    MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS
    Date Cleared
    2000-04-27

    (139 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart. These devices are intended for the perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.
    Device Description
    The Medtronic AortoCoronary Shunt includes an Aortic Root Cannula Assembly, a Y-Tubing Connector Assembly and a set of Arteriotomy Cannulae (2 mm, 3 mm and 4 mm sizes). The Arteriotomy Cannula Assemblies are also available separately for user convenience. The user assembles the components into the final product configuration immediately prior to use. The assembled device diverts oxygenated, arterial blood from the patient's aorta directly to one or two coronary arteries, thereby providing perfusion of an ischemic area of the heart during cardiac surgical procedures
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    K Number
    K000274
    Device Name
    EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
    Manufacturer
    MEDTRONIC CARDIAC SURGICAL PRODUCTS
    Date Cleared
    2000-02-10

    (10 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIAC SURGICAL PRODUCTS

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

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