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510(k) Data Aggregation

    K Number
    K192907
    Device Name
    Advocate PTA Catheter
    Manufacturer
    Merit Medical Systems Inc.
    Date Cleared
    2019-11-26

    (42 days)

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

    Merit Medical Systems Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Advocate PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
    Device Description
    The Advocate PTA Catheter consists of two lumens, a compatible guidewire lumen (0.014", 0.018" or 0.035") extending from guide wire port in the manifold to the catheter distal tip, and an inflation lumen extending from the proximal inflation port in the manifold to the balloon interior. There are various size balloons in the product matrix, ranging from 2.0-12.0mm in diameter and 15-300mm in length. The catheter has two radiopaque marker bands that facilitate visibility and location during the placement and inflation of the balloon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Fr haemostatic or non haemostatic introducer, depending on the model selected.
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    K Number
    K190175
    Device Name
    S-MAK XL
    Manufacturer
    Merit Medical Systems Inc.
    Date Cleared
    2019-04-10

    (68 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    Merit Medical Systems Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merit S-MAK XL™ is intended for percutaneous placement of up to a 0.038" (.097mm) guide wire or catheter into the vascular system.
    Device Description
    The S-MAK XL TM utilizes a small diameter coaxial introducer/dilator pair and guide wire for placement of larger diameter guide wires into the vasculature system when a small needle stick is preferred. The S-MAK XL TM consists of the following components: One (1) 4F Coaxial Introducer/Dilator Pair (30 cm length) One (1) 21 gauge Introducer Needle One (1) 0.018" (0.46mm) 80cm Nitinol/Palladium Guide Wire
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    K Number
    K173621
    Device Name
    Advocate PTA Catheter
    Manufacturer
    Merit Medical Systems Inc.
    Date Cleared
    2017-12-13

    (21 days)

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

    Merit Medical Systems Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, and renal arteries.
    Device Description
    The Advocate PTA Catheter consists of two lumens, a compatible guidewire lumen (0.014", 0.018" or 0.035") extending from guide wire port in the manifold to the catheter distal tip, and an inflation lumen extending from the proximal inflation port in the manifold to the balloon interior. There are various size balloons in the product matrix, ranging from 2.0-12.0mm in diameter and 20-300mm in length. The catheter has two radiopaque marker bands that facilitate visibility and location during the placement and inflation of the balloon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Fr haemostatic or non haemostatic introducer, depending on the model selected.
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    K Number
    K170700
    Device Name
    Inqwire Diagnostic Guide Wire
    Manufacturer
    Merit Medical Systems Inc.
    Date Cleared
    2017-04-06

    (30 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Merit Medical Systems Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.
    Device Description
    Merit InQwire® Amplatz Super Stiff Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure that the guide wire components remain together The outside coil is PTFE coated and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated. The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch and 0.038-inch outer diameter with a 1cm, 3cm, 3.5cm ,4cm, 6cm and 7cm straight and J tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length. The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices.
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    K Number
    K151497
    Device Name
    EN Snare Endovascular Snare System
    Manufacturer
    MERIT MEDICAL SYSTEMS INC
    Date Cleared
    2015-07-01

    (27 days)

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

    MERIT MEDICAL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EN Snare® Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veupuncture procedure assistance.
    Device Description
    The EN Snare Endovascular Snare System consists of four individual components: snare: catheter: insertion tool and torque device. Systems are available in various sizes and lengths. The snare is comprised of 3 interlaced stranded cables of platinum and super-elastic nitinol that form 3 loops and are mechanically secured with a crimp collar to a nitinol shaft wire. The superelastic nitinol construction enables the loops of the snare to be introduced through a catheter without the risk of deformation. The catheter is manufactured with a Pebax outer layer and a PTFE inner layer with an embedded iridium/platinum markerband at the distal end, a Pebax hub and a polycarbonate luer. A snare insertion tool is also included for optional back-end loading of the snare into a preplaced catheter. The snare insertion tool is manufactured from polypropylene. The snare is inserted into an intravascular catheter and manipulated by use of an external torque device. The snare is offered in sizes ranging from 2mm to 45mm, with catheter sizes of 3.2F, 6F, and 7F.
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    K Number
    K142051
    Device Name
    PRELUDE PLASTIC JACKETED GUIDE WIRE
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Date Cleared
    2014-12-17

    (142 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIT MEDICAL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merit plastic jacketed introducer guide wire is intended to facilitate the placement of devices during diagnostic and interventional procedures, specifically sheath introducers. The wire is indicated for the peripheral vasculature only.
    Device Description
    The Merit Prelude Plastic jacketed introducer guide wire consists of a high quality metallic core wire with a radiopaque polymer jacket. The wire will be offered in straight and angled versions, in various lengths.
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