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510(k) Data Aggregation

    K Number
    K213314
    Device Name
    CerusEndo Microcatheter (027)
    Date Cleared
    2022-03-15

    (162 days)

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

    Cerus Endovascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CerusEndo Microcatheter (027) is intended to deliver therapeutic devices within the neurovasculature.
    Device Description
    The subject device is a microcatheter available in two versions: a 150 cm length microcatheter with a 34 cm length distal segment; and a 160 cm length microcatheter with a 34 cm length distal segment. The distal segment of the catheter is flexible to facilitate access into tortuous anatomy, and the distal tip of the catheter is formable, allowing the physician to shape it according to the needs of the procedure at the point of use. The CerusEndo Microcatheter (027) has a hydrophilic coating, radiopaque marker, Luer hub on the proximal end, polymer tapered shaft construction, stainless steel reinforced shaft, and Teflon lined inner lumen. The subject device is controlled by user manipulation to access discrete locations within the vascular anatomy. It is intended to deliver therapeutic devices through its inner lumen. It is designed to be used in neurovascular locations.
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    K Number
    K182487
    Device Name
    CerusEndo Microcatheter
    Date Cleared
    2019-07-20

    (312 days)

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

    Cerus Endovascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CerusEndo Microcatheter is intended for general intravascular use to deliver therapeutic devices to the peripheral, coronary, and neurovasculature.
    Device Description
    The subject device is a microcatheter available in three versions: a 150 cm length microcatheter with a 15 cm length distal segment; a 150 cm length microcatheter with a 34 cm length distal segment; and a 160 cm length microcatheter with a 42 cm length distal segment. The distal segment of the catheter is flexible to facilitate access into tortuous anatomy, and the distal tip of the catheter is formable, allowing the physician to shape it according to the needs of the procedure at the point of use. The CerusEndo Microcatheter has a hydrophilic coating, radiopaque marker, Luer hub on the proximal end, polymer tapered shaft construction, stainless steel reinforced shaft, and Teflon lined inner lumen. The subject device is controlled by user manipulation to access discrete locations within the vascular anatomy. It is intended to deliver other interventional or therapeutic devices through its inner lumen. It is designed to be used in peripheral, coronary, and neurovascular locations.
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