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510(k) Data Aggregation

    K Number
    K961717
    Device Name
    NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS
    Date Cleared
    1996-07-18

    (77 days)

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

    NALTIAC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NMI Retrograde Cardioplegia Cannulae-RCCS are intended for use in perfusing blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery.
    Device Description
    The NMI Retrograde Cardioplegia Cannulae are fabricated with polyvinyl chloride bodies (PVC) and polyurethane balloon cuffs, polycarbonate/polyethylene stopcocks, polypropylene clamps, PVC female luer connectors, and stainless steel guidewires. The features of the device include: self-inflating cuff, pressure monitoring port with 3-way stopcock on jumen extension, suture ing. and 14 French size. The cannulae are placed in the coronary sinus in order to infuse cardioplegia in a retrograde fashion to the myocardium. This practice both arrests the heart and preserves metabolic function during surgery.
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    K Number
    K961180
    Device Name
    NMI ANTEGRAD CARDIOPLEGIA CANNULA
    Date Cleared
    1996-06-21

    (87 days)

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

    NALTIAC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NMI Antegrade Cardioplegia Cannulae are intended to be used to deliver cardioplegia solutions to the heart or venting cardioplegia away from the heart via the ascending aora. The cannulae may also be use to aspirate air from the ascending aorta.
    Device Description
    The NMI Antegrade Cannulae are manufactured in vented and non-vented and non-vented 12 and 14 gauge. The devices consist of a PVC catheter body with optional vent line, radiopaque flexible PVC tip, stainless steel needle stylet, vent line adapter, polypropylene pinch clamp, PVC suture ring and PVC female luer lock connector.
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    K Number
    K961181
    Device Name
    NMI VEIN GRAFT PERFUSION SET
    Date Cleared
    1996-06-21

    (87 days)

    Product Code
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    NALTIAC MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NMI Vein Graft Perfusion Set is intended to be used during a cardiopulmonary bypass procedure to connect multiple coronary cannulae to a single infusion line.
    Device Description
    The NMI Vein Graft Perfusion Set is fabricated with PVC alloy tubing, PVC Quad fitting, polypropylene pinch clamp, PVC female luer connector, and ABS male luer connector. The features of the device include: one 3 1/4 inlet leg with female luer port and white pinch clamp, three 9 3/4 in. outlet legs with red pinch clamps terminating in male luer lock connectors, one 3 1/4 in. outlet leg with blue pinch clamp terminating in a male luck, and soft flexible tubing on legs, .090 1.D., and 3/16 O.D.
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