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510(k) Data Aggregation

    K Number
    K233205
    Device Name
    Distal Access Catheter
    Date Cleared
    2023-12-22

    (85 days)

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

    Shanghai HeartCare Medical Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.
    Device Description
    The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.
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