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510(k) Data Aggregation

    K Number
    K241040
    Device Name
    Amethyst HP PTA OTW 0.035 Catheter
    Manufacturer
    Natec Medical Ltd.
    Date Cleared
    2024-12-18

    (246 days)

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

    Natec Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amethyst HP PTA OTW 0.035" catheter is indicated for: - Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. - Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature
    Device Description
    The Amethyst HP PTA OTW 0.035 catheter is a balloon catheter consisting of an over the wire catheter with a non-compliant inflatable balloon fixed at the distal end of the tip. The balloons are designed to provide consistent balloon diameters and lengths at high pressures. A radiopaque tapered tip positioned at distal of the balloon facilitates the advancement of the catheter to and through the stenosis. A Luer lock fitting (Y hub) at the proximal end allows connection with an inflation device. The catheter is a co-axial catheter with a balloon at the distal tip. One lumen is used for the inflation of the balloon and is accessed via the lateral port of the Y hub. The second lumen, start at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The balloon has two radiopaque markers to aid in positioning the balloon relative to stenosis. The balloon is dilated using the lateral port, at which the balloon opens to a known diameter at a specific pressure. The maximum recommended guide wire diameter is 0.035". The catheter is supplied sterile and is intended for single use.
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    K Number
    K220410
    Device Name
    Ebony HP PTA OTW 0.035 Catheter
    Manufacturer
    Natec Medical Ltd.
    Date Cleared
    2022-06-29

    (135 days)

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

    Natec Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ebony HP PTA OTW 0.035" Catheter is indicated for; · Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. · Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
    Device Description
    The Ebony HP PTA OTW 0.035" Catheter is a standard Over The Wire (OTW) PTA catheter with a non-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end to facilitate advancement of the catheter through the stenosis, and a luer lock fitting (Y hub) at the proximal end allowing the connection with an inflation device. The catheter is a two lumen catheter; one lumen is used for inflation of the balloon and accessed via the lateral port of the Y hub. The second lumen, starting at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The maximum recommended guide wire diameter is 0.035". The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. The working pressure range for the balloon is between the nominal pressure (NP) and the rated burst pressure (RBP). A hydrophilic coating solution is applied on the distal section of the shaft and on the balloon to improve the pushability of the catheter by reduction of the friction coefficient of the outer body.
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    K Number
    K210012
    Device Name
    Tamarin Blue PTCA RX Dilatation Catheter
    Manufacturer
    Natec Medical Ltd.
    Date Cleared
    2021-07-09

    (186 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Natec Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tamarin Blue PTCA RX Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
    Device Description
    The Tamarin Blue PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter. The device is supplied sterile and intended for one-time use.
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