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510(k) Data Aggregation

    K Number
    K202926
    Device Name
    Micro Catheter
    Date Cleared
    2022-02-10

    (499 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 Micro Catheter is intended for selective delivery of therapeutic devices and infusion of contrast media into the peripheral and neuro vasculature.
    Device Description
    The proposed device Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the peripheral and neuro vasculature. The proximal end of the catheter incorporates standard Luer adapter to facilitate the attachment of accessories. The outer surface of the catheter has a lubricious coating at the distal end of the Micro Catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The device is intended for single use and is provided sterile.
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    K Number
    K202916
    Device Name
    Balloon Guiding Catheter
    Date Cleared
    2021-08-25

    (330 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 Balloon Guiding Catheter is intended to assist intravascular catheterization and guidance of an intravascular catheter into a selected vessel in the neuro or peripheral vascular system. The balloon can provide temporary vascular occlusion during angiography.
    Device Description
    The proposed device, Balloon Guiding Catheter, is a braid-reinforced, variable stiffness catheter designed for use in facilitating the guidance of an intravascular catheter into a target vessel in the neuro or peripheral vascular system. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The proposed device is divided into the S and S+ types with different effective lengths, the difference between S type is the size of the catheter.
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