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510(k) Data Aggregation

    K Number
    K142192
    Device Name
    Insightra Freedom Ventral Hernia Repair System
    Manufacturer
    Date Cleared
    2015-05-07

    (269 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Insightra Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Insightra Freedom Ventral Hernia Repair System is intended for use in the open repair of ventral hernias.
    Device Description
    The Insightra Ventral Hernia Repair System is composed of a polypropylene woven mesh implant and a disposable Strap Passer accessory that is used during the surgical implantation. The mesh implant is an oval shape with 8 straps that extend radially from the oval portion. The straps are used to secure the mesh to the implantation site, similar to traditional methods such as suturing or stapling. During the implantation procedure, the straps are then trimmed below the skin and become incorporated in the muscle tissue.
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    K Number
    K140967
    Device Name
    FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
    Manufacturer
    Date Cleared
    2014-06-10

    (57 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Insightra Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exist.
    Device Description
    The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The entire implant is made from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the Delivery Device provided in the Freedom Inquinal Hernia Repair Kit. The Delivery Device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. Currently, the implants come in two different sizes; 25mm and 40mm with corresponding Delivery Devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.
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    K Number
    K113552
    Device Name
    FREEDOM INGUINAL HERNIA IMPLANT
    Manufacturer
    Date Cleared
    2012-08-23

    (266 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Insightra Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exists.
    Device Description
    The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The implant is wholly manufactured from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the delivery device provided in the Freedom Inguinal Hernia Repair kit. The delivery device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. There are two different sizes of implants and corresponding delivery devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.
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    K Number
    K082746
    Device Name
    ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
    Date Cleared
    2009-01-12

    (115 days)

    Product Code
    Regulation Number
    870.3535
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSIGHTRA MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultra IABP is placed in the descending aorta just below the subclavian artery. and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory feft ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic perculaneous revascularization and interventional procedures, ischemic related intractable ventricular arrhythmias, septic shock, interoperative pulsatile flow generation, weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery, prophylactic support in preparation for cardiac surgery, post-surgical myocardial dysfunction/low cardiac output syndrome, cardiac contusion, mechanical bridge to other assist devices and cardiac support following correction of anatomical defects.
    Device Description
    The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors). The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the hearbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.
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