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510(k) Data Aggregation

    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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