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510(k) Data Aggregation

    K Number
    K041650
    Device Name
    MICRO PRIME
    Date Cleared
    2004-08-16

    (60 days)

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

    INNOVX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Micro Prime Delivery Lines are indicated for use to convey arterial blood and cardioplegia with minimal prime volume in the extracorporeal circuit.
    Device Description
    Micro Prime Delivery Lines minimize the blood prime volume in the extracorporeal circuit. For pediatric cardiopulmonary bypass, where excessive priming volume can increase surgical risk, Micro Prime delivery lines offer a distinct advantage. Micro Prime Delivery Lines consist of a dual lumen extrusion: a round "blood" lumen used to convey blood to/from the patient, and a crescent shaped "occlusion" lumen which surrounds the blood lumen, and is used to purge excess prime volume from the blood lumen. In use, both lumens are initially primed with saline. Once the tubing has been primed, the occlusion lumen is pressurized with additional saline, collapsing the blood lumen and purging excess priming fluid from the blood lumen. Releasing the pressure from the occlusion lumen causes the blood lumen to re-open to its normal shape. In this manner, Micro Prime Delivery Lines regligible blood volume to prime as compared to conventional delivery lines.
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