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510(k) Data Aggregation

    K Number
    K121415
    Device Name
    MOLLRING MULTITASC
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2012-09-05

    (117 days)

    Product Code
    DWX
    Regulation Number
    870.4875
    Why did this record match?
    Product Code :

    DWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for remote endarterectomy of peripheral blood vessels during vascular reconstruction.
    Device Description
    The MollRing MultiTASC is a single use, sterile and disposable device designed for vascular surgeons use during remote endarterectomy procedures for the facilitation of dissecting, cutting and removing atheromatous plaque core within the peripheral vascular system. The Subject Device is a fixed, circumferential, blunt-edged, sterile, single use cutting tool. It consists of two stainless steel coaxial metal rings (proximal and distal rings) which are connected by a stainless steel rod and hypo tube system. The modular rod and hypo tube system connects to a plastic operator's handle with selective positions for ring alignment (cutting/dissecting phase). The device is introduced over the proximal end of the atheromatous plaque core of a peripheral vascular vessel. With the two stainless steel coaxial metal rings in "alignment position", they are advanced to the distal end of the plaque core. As the device transverses the vessel it acts as a conventional circumferential dissection ring stripper, removing the plaque core to the distal endpoint. The device is then switched via the operator handle to "un-alignment position", which spreads the distal and proximal rings, thus cutting and securing the plaque core. Once secured, the device is withdrawn, facilitating the core removal.
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    K Number
    K032105
    Device Name
    ENDOHELIX ENDARTERECTOMY DEVICE
    Manufacturer
    ENDARX, INC.
    Date Cleared
    2003-10-30

    (114 days)

    Product Code
    DWX
    Regulation Number
    870.4875
    Why did this record match?
    Product Code :

    DWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.
    Device Description
    The EndoHelix endarterectomy device is a tubular device with an expanding helical element at the distal tip. The expandable helical element is controlled by the user with a sliding tab on the handle. The device is designed to be used with or without a guidewire. The device is packaged in an industry standard Tyvek/Mylar pouch and is provided sterile. The EndoHelix device is a single use product and is not intended to be resterilized or reused.
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    K Number
    K020925
    Device Name
    CARBODISSECTING ENDOSCOPE
    Manufacturer
    ENDO SURGICAL DEVICES, INC.
    Date Cleared
    2003-04-29

    (404 days)

    Product Code
    DWX
    Regulation Number
    870.4875
    Why did this record match?
    Product Code :

    DWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carbodissecting Endoscope is designed for use in intraluminal tissue separation during a femoro-popliteal endarterectomy procedure intended to achieve vascular reconstruction. The device is an adjunctive aid in the separation of vessel layers.
    Device Description
    The Carbodissecting Endoscope, sterile and single-use, consists of two components: The spatula is a surgical tool used with carbon dioxide (CO2) and saline for atherectomy using carbodissection. The scope is a flexible fiberscope intended for use with the Carbodissecting Endoscope Spatula to provide visual feedback.
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    K Number
    K003719
    Device Name
    VASCULAR ARCHITECTS PERISCOPE DEVICE
    Manufacturer
    VASCULAR ARCHITECTS, INC.
    Date Cleared
    2001-02-28

    (86 days)

    Product Code
    DWX
    Regulation Number
    870.4875
    Why did this record match?
    Product Code :

    DWX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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