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510(k) Data Aggregation

    K Number
    K250105
    Device Name
    Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
    Manufacturer
    Aveera Medical, Inc.
    Date Cleared
    2025-07-03

    (169 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K221902
    Device Name
    LimFlow Vector
    Manufacturer
    LimFlow, Inc.
    Date Cleared
    2022-12-21

    (174 days)

    Product Code
    MGZ, LIM
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
    Device Description
    The LimFlow Vector is a single-use medical device designed to cut venous valves during vascular in-situ bypass procedures. The LimFlow Vector consists of a 4Fr intravascular catheter that has a working length of 120cm. It utilizes a deployment mechanism to deploy the self-expanding nitinol cutting basket mounted at distal tip which self-centers in the vessel to prevent the cutting blades from damaging the vessel wall. The size of the cutting basket and cutting blades adjust to the internal diameter of the vein as the LimFlow Vector is being drawn through the vessel. The LimFlow Vector is compatible with 0.018" standard guide wires. The LimFlow Vector is used in a healthcare facility, such as a catheter lab or hospital. It is in contact with patient tissue for less than 24 hours. The LimFlow Vector is supplied sterile.
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    K Number
    K190267
    Device Name
    EZE SIT Valvulotome
    Manufacturer
    LeMaitre Vascular
    Date Cleared
    2019-10-30

    (264 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.
    Device Description
    The EZE SIT Valvulotome is a medical device utilized for disruption of venous valves, and is used in patients that suffer from peripheral vascular disease, for which an attending physician determines the relative benefit of in situ bypass to restore blood flow to the extremities. The EZE-SIT Valvulotome is comprised of a catheter with a luer-lock hub at the proximal end and a threaded connector at the distal end. The catheter is designed with a lumen that extends throughout its entire length. The threaded connector allows attachment of 2 mm, 3 mm and 4 mm diameter cutting heads. These cutting heads are also configured with a central lumen. This design allows the physician to select the cutter head diameter that is best suited for the particular vessel being prepared. The central lumen allows irrigation during the procedure. The cutting head design minimizes vessel wall contact while effectively disrupting valve leaflet tissue. The EZE SIT Valvulotome is surgically invasive and intended for less than 24-hour use. This medical device has no software components. This device is not an in vitro diagnostic device.
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    K Number
    K142660
    Device Name
    Antegrade LeMills Valvulotome
    Manufacturer
    LeMaitre Vascular, Inc.
    Date Cleared
    2014-10-17

    (29 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMills Valvulotomes are intended to cut venous valves.
    Device Description
    The Antegrade LeMills Valvulotome consists of small metal antegrade cutting blade with atraumatic distal edge. The blade is a part of a long stainless steel wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.
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    K Number
    K140042
    Device Name
    1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2014-04-10

    (92 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves.
    Device Description
    The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering and self-sizing valvulotome device used for cutting vein valves. The centering hoops keep the device centered in the vein. The size of the centering hoops and cutting blades adjust to the internal diameter of the vein as the valvulotome is being drawn through the vessel cutting the valves and rendering them ineffectual. The modifications to the predicate device - Expandable LeMaitre Valvulotome (ELV)- include the addition of hydrophilic coatings and co-extruded sheath to create 1.5mm HYDRO Expandable LeMaitre Valvulotome. The hydrophilic coatings provide increased lubricity and allow the device to navigating veins easier.
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    K Number
    K132047
    Device Name
    LEMILLS VALVULOTOME
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2013-11-05

    (126 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMills Valvulotome is intended to cut venous valves.
    Device Description
    The LeMills Valvulotome consists of small metal retrograde cutting blade with atraumatic distal edge. The blade is a part of a long section of wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.
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    K Number
    K132190
    Device Name
    EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2013-08-05

    (21 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
    Device Description
    The ELV and OTW-LV are self-centering and self-sizing valvulotome used for blind lysis of vein valves. Once the valves have been rendered ineffectual, it can then be utilized as an arterial conduit. Centering hoops keep the devices centered in the vein and prevent the valve-cutting blades from damaging the vein wall. The size of hoops and blades adjusts to the internal diameter of the vein as the valvulotome is being drawn through the vessel. The OTW-LV facilitates navigation of the vein with the assistance of a guidewire.
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    K Number
    K111884
    Device Name
    OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2011-07-29

    (28 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during in-situ bypass.
    Device Description
    The OTW ELV is a self-centering and self-sizing catheter used for cutting valves in the saphenous vein while navigating over a guidewire.
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    K Number
    K080178
    Device Name
    VALVULOTOME BY KOVEN
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2008-07-28

    (186 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Valvulotome by Koven Valvulotome is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.
    Device Description
    The Valvulotome by Koven is a medical device that has a deployable assembly with multiple deployable cutting blades and guide fins which permit continual centralizing, and alignment of the cutting blades within the lumen of the vein as the valves are being cut. The device includes a handle operatively associated with this deployable assembly through a catheter operated by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position. The Valvulotome by Koven consists of three main parts; the handle, the catheter and the cutter head.
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    K Number
    K022823
    Device Name
    VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
    Manufacturer
    GEISTER MEDIZINTECHNIK GMBH
    Date Cleared
    2004-07-01

    (675 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Product Code :

    MGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Geister Valvulotomeare designed to incise the valve cusps of the graft in coronary artery bypass graft (CABG) procedures.
    Device Description
    Not Found
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