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510(k) Data Aggregation

    K Number
    K991093
    Device Name
    MSD EMBOLECTOMY BASKET
    Manufacturer
    METAMORPHIC SURGICAL DEVICES, LLC.
    Date Cleared
    2000-12-21

    (630 days)

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

    METAMORPHIC SURGICAL DEVICES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in removal of fresh, soft clot from vessels of the arterial system. NOT for use in the prevention of distal embolization during endovascular interventions. NOT for use in the carotid arteries.
    Device Description
    The MSD™ Embolectomy Basket is a single use basket (not a ballon) for capture and removal of emboli. It has five components: a flexible sack of a bio-compatible material; a wire frame of shape-memory-effect alloy (specifically, Nitinol) in its superelastic state; a bio-compatible sheath; a wire linkage within the sheath connecting the frame to a handle. The flexible, kink resistant wire linkage slides within the sheath. The proximal ends of both the sheath and the wire linkage are mounted to a handle. The distal end of the wire linkage is attached to the frame. The mouth of the sack, made of a thin, flexible material, is bonded to the loop formed by the frame. The wire frame can be retracted into the sheath by operation of the handle. This process first closes the mouth of the sack and then configures it for retraction with the frame into the sheath.
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