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510(k) Data Aggregation

    K Number
    K212988
    Device Name
    ONO Retrieval Device
    Manufacturer
    Onocor Vascular LLC
    Date Cleared
    2022-05-23

    (245 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Onocor Vascular LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Onocor ONO Retrieval device is indicated for use in the cardiovascular system to retrieve objects using minimally invasive surgical procedures include retrieval of intravascular foreign objects such as coils, balloons, catheters, guidewires and/or filters within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.
    Device Description
    The ONO Retrieval device is constructed of 12 Fr stainless steel reinforced catheter, a series of braided nitinol loops forming a basket, a peel away sheath, inner catheter and stop-cocks. The peel away sheath is advanced to compress the nitinol basket for introduction and then removed. The ONO is compatible with up to a 7 Fr manipulation device or snare and with 12Fr to 26 Fr retrieval sheaths. The ONO has a working length of 86 cm.
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