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510(k) Data Aggregation

    K Number
    K980128
    Device Name
    BALADI INVERTER WITH COAXIAL AORTIC PUNCH
    Manufacturer
    CARDIO MEDICAL SOLUTIONS, INC.
    Date Cleared
    1998-07-24

    (191 days)

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

    CARDIO MEDICAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Baladi Inverter™ with Coaxial Aortic Punch is intended for use by cardiac surgeons during Coronary Artery Bypass Grafting procedures to maintain hemostasis and punch a hole in the aorta to facilitate the completion of the proximal anastomosis.
    Device Description
    The Baladi Inverter™ with Coaxial Aortic Punch is used to create hemostasis and punch a hole in the aorta to facilitate the anastomosis during coronary arterial bypass grafting (CABG) procedures.
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