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510(k) Data Aggregation

    K Number
    K220920
    Device Name
    Matreneu Percutaneous Balloon Compression Kit
    Date Cleared
    2022-09-07

    (161 days)

    Product Code
    Regulation Number
    882.4535
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Shineyard Medical Device Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Matreneu® Percutaneous Balloon Compression Kit is intended to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
    Device Description
    The Matreneu® Percutaneous Balloon Compression Kit is intended to be used to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia. The subject device consist of five parts, such as the balloon catheter, puncture needle, svringe, connector, and pressure gauge. Through a sheath under X-ray fluoroscopy. a micro-balloon is introduced into the meniscus of the trigeminal nerve in Meckel's cavity to assist in retraction and establishment of a pathway. Then inject the contrast agent to fill the balloon to relieve the compression of the nerve fibers that cause trigeminal neuralgia. And through the expansion of the micro-balloon compression injury to treat trigeminal neuralgia. The Kit is supplied sterile and is intended for single use.
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