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510(k) Data Aggregation

    K Number
    K133017
    Device Name
    ESTECH COBRA(R) GENESIS BIPOLAR CLAMP
    Manufacturer
    ESTECH, INC.
    Date Cleared
    2013-10-07

    (11 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Estech COBRA® Genesis Bipolar Clamp is intended for the coagulation of soft tissue during general surgery. The system may also be used to coagulate blood and soft tissue to produce hemostasis.
    Device Description
    The Estech COBRA® Genesis Bipolar Clamp is a sterile, single-use device designed to guide RF energy to the target tissue via electrodes in the jaws of a surgical clamp style device. RF energy is delivered in a bipolar mode, with one jaw of the device as the ablative electrode and the other jaw as the indifferent electrode.
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    K Number
    K053021
    Device Name
    ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
    Manufacturer
    ESTECH, INC.
    Date Cleared
    2006-01-26

    (92 days)

    Product Code
    DTS
    Regulation Number
    870.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH Clearview™ MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.
    Device Description
    The Estech Clearview™ MV Atrial Depressor is a sterile, single use, surgical instruments intended for the collection of blood and other fluids from the surgical field for return through the cardiotomy system during open heart surgery. The a molded polymer proximal connector is intended to connect into cardiopulmonary bypass system to return blood and fluids into the extracorporeal circulation circuit, most typically during stoppedheart surgical procedures. The Estech Clearview™ MV Atrial Depressor has an integrated shaft designed to connect to the Estech Small Incision Retractor. The retractor creates access to the surgical field via thoracotomy or mini-sternotomy. When mounted to the retractor, the Estech Clearview™ MV Atrial Depressor can also be used to retract tissues while collecting fluids.
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    K Number
    K052081
    Device Name
    REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
    Manufacturer
    ESTECH, INC.
    Date Cleared
    2005-12-16

    (136 days)

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

    ESTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to 6 hours.
    Device Description
    The Estech Remote Access Perfusion (RAP™) Femoral Venous Cannula is a sterile, single-use, open-ended, hollow polymer tube with multiple perforations at the distal end. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. The RAP FV cannula is provided with a flexible obturator to assist with the placement. The RAP FV cannula can be guided over a 0.035" guidewire. The RAP FV cannula has depth markers to assist the physician with placement. The RAP FV cannula ranges in outside diameter from 18 - 26 Fr, and in length from 60 -76 cm.
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    K Number
    K051749
    Device Name
    COBRA SURGICAL SYSTEM
    Manufacturer
    ESTECH, INC.
    Date Cleared
    2005-09-13

    (76 days)

    Product Code
    GEI, GEL, OCL
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Estech Cobra Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
    Device Description
    The Estech Cobra Surgical System is a family of devices including RF Ablation Probes, with either a malleable or flexible shafts, used in conjunction with the Cobra Electrosurgical Unit (ESU) and other accessories, including the Estech Cobra Bipolar Recording Electrode. The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.
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    K Number
    K041599
    Device Name
    COBRA ADHERE SURGICAL SYSTEM
    Manufacturer
    ESTECH, INC.
    Date Cleared
    2004-07-27

    (43 days)

    Product Code
    GEI, OCL
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Estech Cobra Adhere Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
    Device Description
    The Cobra Adhere Surgical System is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.
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    K Number
    K032632
    Device Name
    REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
    Manufacturer
    ESTECH, INC.
    Date Cleared
    2003-10-22

    (57 days)

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

    ESTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (< 6 hours). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.
    Device Description
    The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is a disposable 31 cm long flexible polyurethane tube with three (3) lumens with an inflatable polyurethane balloon at the distal end of the cannula. The inflatable balloon has elastomeric properties designed to provide aortic occlusion in a range of aorta sizes with internal diameters from 22 mm to 34 mm. The outside diameter of the cannula is 21 Fr. (7 mm). The cannula has a central lumen for the delivery of arterial blood through multiple distal outlets at flow rates of 1.0 to 5.0L/min, a lumen that communicates with the aorta in the area of the aortic root for delivery of cardioplegia solution and left ventricle venting, and a small lumen for control of the distal balloon. Radio-opaque arch segment of cannula and insertion depth marks aid in positioning the device. The Cannula are provided sterile in individual packages for single use.
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    K Number
    K990573
    Device Name
    ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
    Manufacturer
    ESTECH, INC.
    Date Cleared
    1999-03-11

    (16 days)

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

    ESTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.
    Device Description
    The ESTECH Arterial Remote Access Perfusion Cannula is a sterile, disposable, flexible polyurethane tube with three integrated lumens and an inflatable polyurethane balloon at the distal end of the cannula. The outside diameter of the cannula is 21 French. The cannula has a central lumen for delivery of arterial blood through multiple distal outlets at a flow rate up to 5 liters per minute, a small lumen for delivery of cardioplegia or venting at the aortic root, and an additional smaller lumen for control of the distal balloon. The blood outlet ports are multiple elongated openings along the cannula proximal to the occlusion balloon. Radiopaque balloon markers and insertion depth marks aid in positioning the device. The cannulas are provided sterile in individual packages for single use.
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