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510(k) Data Aggregation

    K Number
    K242154
    Device Name
    Numen™ Coil Embolization System; NumenFR™ Detachment System
    Manufacturer
    MicroPort NeuroTech (Shanghai) Co., Ltd.
    Date Cleared
    2024-09-30

    (69 days)

    Product Code
    HCG, KRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroPort NeuroTech (Shanghai) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen™ Coil Embolization System is indicated for endovascular embolization of: - . Intracranial aneurysms - Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae - . Arterial and venous embolizations in the peripheral vasculature NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
    Device Description
    The Numen™ Coil Embolization System is composed of two parts as described below: - An introducer sheath: The function of the introducer sheath is to facilitate introduction . of the coil into the microcatheter. - . The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. The MicroPort NeuroTech NumenFR™ Detachment System is a sterile, handheld, singlepatient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
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    K Number
    K232955
    Device Name
    Numen Coil Embolization System; NumenFR Detachment System
    Manufacturer
    MicroPort NeuroTech (Shanghai) Co., Ltd.
    Date Cleared
    2024-01-10

    (111 days)

    Product Code
    HCG, KRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroPort NeuroTech (Shanghai) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen™ Coil Embolization System is indicated for endovascular embolization of: -Intracranial aneurysms -Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae -Arterial and venous embolizations in the peripheral vasculature NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
    Device Description
    MicroPort NeuroTech has developed the Numen™ Coil Embolization System and NumenFR™ Detachment System. The Numen™ Coil Embolization System is designed to be used in conjunction with the NumenFRTM Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen™ Coil Embolization System is composed of two parts as described below: - . An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. - . The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. The MicroPort NeuroTech NumenFRTM Detachment System is a sterile, handheld, single-patient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
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    K Number
    K203625
    Device Name
    Numen Coil Embolization System; NumenFR Detachment System
    Manufacturer
    MicroPort NeuroTech (Shanghai) Co., Ltd.
    Date Cleared
    2021-09-01

    (264 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    MicroPort NeuroTech (Shanghai) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen™ Coil Embolization System is indicated for endovascular embolization of: - Intracranial aneurysms - Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae - Arterial and venous embolizations in the peripheral vasculature NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
    Device Description
    The Numen™ Coil Embolization System is designed to be used in conjunction with the NumenFRTM Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen™ Coil Embolization System is composed of an introducer sheath and the coil system (pusher and coil implant). The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. The MicroPort NeuroTech NumenFRTM Detachment System is a sterile, handheld, single-patient use device designed for use with MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
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