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510(k) Data Aggregation

    K Number
    K182167
    Device Name
    The ICHOR Panacea Vascular Embolectomy Catheter System
    Manufacturer
    ICHOR Vascular, Inc.
    Date Cleared
    2018-12-21

    (133 days)

    Product Code
    QEWDXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ICHOR Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Panacea embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature, and is not intended for use in the coronary or neurovasculature.
    Device Description
    The fundamental mechanism of action is temporary vessel occlusion combined with mechanical balloon embolectomy and aspiration through a guide catheter. The sheath provides vessel access. The occlusion balloon catheter is intended for temporary vessel occlusion and the guide catheter functions to remove emboli and thrombi. The devices are provided sterile, non-pyrogenic, and intended for single use only.
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