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510(k) Data Aggregation

    K Number
    K171819
    Device Name
    Attain Assist CS Access Catheter
    Date Cleared
    2018-01-04

    (199 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Creganna Medical also doing business as Ceganna Tactx Medica

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Attain Assist™ CS Access Catheter is a left-heart CS catheter intended to enable access to the left heart via the coronary sinus.
    Device Description
    The Medtronic Attain Assist™ CS Access Catheter is a sterile, single-use intravascular catheter used to facilitate access to the left heart via the coronary sinus. The device consists of a braid reinforced catheter shaft with a curve at the distal end and a hub luer connection with a strain relief and a detachable cap at the device. The detachable cap prevents leakage from the catheter when a guide wire is not being used. At the distal end of the catheter shaft, six (6) radiopaque marker bands are embedded into the shaft which provide a visual aid under fluoroscopy during device positioning in the left heart. A stainless steel tip is attached to the distal edge of the braided catheter shaft to provide an atraumatic lead for the catheter during delivery. The Attain Assist™ CS Access Catheter is compatible with guide catheters with inner diameter of 6.5Fr or greater. The device is supplied as a single use sterile device.
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