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510(k) Data Aggregation

    K Number
    K173323
    Device Name
    AnastoClip GC Closure System
    Manufacturer
    LeMaitre Vascular, Inc.
    Date Cleared
    2018-03-08

    (139 days)

    Product Code
    FZP, HBT
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LeMaitre Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular structures when tissue penetration is desired. The Applier is also intended for approximation of durotomies following open craniotomy and open spinal laminectomy procedures.
    Device Description
    AnastoClip GC Closure System is designed to create everting anastomoses of tissue. It includes the applier, clip remover, and atraumatic forceps. The AnastoClip GC applier consists of a rotating shaft and an integral cartridge containing titanium clips. As the levers of the applier are squeezed together, the clip is closed around the everted tissue edges. As the levers are released, a new clip is automatically loaded into the clip applier jaws. It is recommended, with each procedure, to use the atraumatic everting forceps to aid in the everting of the tissue edges. It is also recommended, with each procedure, to use the AnastoClip Remover for the removal of any AnastoClip GC clips when needed.
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    K Number
    K152833
    Device Name
    Pruitt F3-S Polyurethane Carotid Shunt
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2016-01-21

    (114 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEMAITRE VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pruitt F3-S Polyurethane Carotid Shunt is in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
    Device Description
    The Pruitt F3-S Polyurethane Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3-S Polyurethane Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The Pruitt F3-S Polyurethane Carotid Shunt is not made of natural rubber latex.
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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?
    Applicant Name (Manufacturer) :

    LeMaitre Vascular, Inc.

    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?
    Applicant Name (Manufacturer) :

    LEMAITRE VASCULAR, INC.

    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
    K133026
    Device Name
    UNBALLOON NON-OCCLUSION MODELING CATHETER
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2013-12-31

    (96 days)

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

    LEMAITRE VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.
    Device Description
    The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling Catheter with an expandable Nitinol mesh in a retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh. This submission modifies the current UnBalloon Non-Occlusive Modeline Catheter to be able to deliver higher radial outward force in order to improve stent graft modeling effectiveness (i.e., apposition of the stent graft with the vessel lumen). this device modification increases the outer diameter of the thoracic models from 14 Fr to 16 Fr.
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    K Number
    K132022
    Device Name
    LEMAITRE 8F OCCLUSION CATHETER
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2013-11-06

    (128 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEMAITRE VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LeMaitre 8F Occlusion Catheter is indicated for temporary vessel occlusion.
    Device Description
    The 8F Occlusion Catheters is offered in two balloon sizes; 28 mm or 45mm. It is a single lumen catheter with a latex balloon specifically designed and sized for use in the outlined general procedures. The single lumen (inflation lumen indicated by the white stopcock) is used for balloon inflation. The stop-cock is to maintain balloon inflation level throughout the procedure. The device has radiopaque marker bands at the proximal and distal ends of the balloon to enhance visibility of the balloon location when used under fluoroscopy.
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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?
    Applicant Name (Manufacturer) :

    LEMAITRE VASCULAR, INC.

    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?
    Applicant Name (Manufacturer) :

    LEMAITRE VASCULAR, INC.

    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
    K130016
    Device Name
    LIFESPAN EPTFE VASCULAR GRAFT
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2013-02-05

    (35 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEMAITRE VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LeMaitre LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.
    Device Description
    LifeSpan Vascular Grafts are consisting of a base tube of expanded PTFE that is wrapped with PTFE tape for better strength. Externally supported grafts have a monofilament of PTFE wrapped over the tape for added crush and kink resistance. The stepped and tapered grafts have a small diameter end and a large diameter end. All models of the graft have a printed black orientation line consisting of "LeMaitre LifeSpan" printed repeatedly along the length of the graft. This 510k is to add an alternative ink for the printing the orientation line.
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    K Number
    K123531
    Device Name
    UNBALLOON NON-OCCLUSIVE MODELING CATHETER
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2012-12-14

    (28 days)

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

    LEMAITRE VASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.
    Device Description
    The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling catheter with an expandable Nitinol mesh in a 14F retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh. This submission modifies the current UnBalloon Non-Occlusive Modeling Catheter by expanding the product family line with additional nitinol mesh cage sizes and catheter lengths.
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