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510(k) Data Aggregation

    K Number
    K243691
    Device Name
    LiquID .051 LP Guide Catheter Extension
    Date Cleared
    2025-04-04

    (129 days)

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

    Seigla Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LiquID Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
    Device Description
    The LiquID .051 LP Guide Catheter Extension device is a guide catheter extension that is substantially equivalent to the currently marketed devices with the distinction of having a smaller intraluminal diameter. Guide catheter extensions (GCE) are designed to facilitate the placement of interventional devices. During common clinical practice, a GCE is advanced over a guidewire from within the interior lumen and beyond the distal tip of a conventional guide catheter. These devices allow physicians to achieve deeper vascular intubation providing enhanced placement and support. The device is currently available in two models: Liquid 061 and LiquID 071 which are designed to fit within 6F and 7F conventional guide catheters, respectively. The LiquID .051 LP Guide Catheter Extension fits within a 6F conventional guide catheter. The 150cm device has a stainless-steel shaft connected to a 15cm single lumen tube. The 15cm single lumen tube catheter body contains a coil for kink resistance and radiopacity. The single lumen tube catheter body is also silicone coated for lubricity. The device has two proximal positioning marks located at 95cm and 105cm from the distal tip. The device handle is color coded to match the standard guide catheter color code.
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    K Number
    K220691
    Device Name
    LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
    Date Cleared
    2022-05-05

    (57 days)

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

    Seigla Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LiquID Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
    Device Description
    The LiquID device is a guide catheter extension that is substantially equivalent to currently marketed devices with the distinction of having a larger intraluminal diameter. The device is available in two models: Liquid 061 and LiquID 071 which are designed to fit within 6F and 7F conventional guide catheters, respectively. The device has a 150 cm working length and a 0.018" diameter proximal stainless-steel shaft connected to a 15cm single lumen distal shaft (exchange length). The LiquID device distal shaft includes an internal PTFE liner, a MP35N coil internally clad with a tantalum core for support and radiopacity, and an exterior nylon-based encapsulation layer. The rounded and atraumatic distal tip includes PTFE and Pebax that is monolithically attached (no joints) to the distal shaft. The distal shaft exterior is wiped with silicone fluid for lubricity. The transition between the single lumen distal shaft and proximal shaft includes a stainless collar that is welded to the proximal shaft, positioned over the PTFE liner, and encapsulated in polymer. This construction provides a smooth transition and structural integrity. The LiquID device has proximal positioning marks (laser created oxide marks) that are approximately 95cm and 105cm from the distal tip and has a colored proximal handle that follows the coronary guide catheter size color code. The proximal shaft is not coated. The LiguID device is packaged in a HDPE hoop within a Tyvek poly sealed pouch. The pouch is contained in an SBS shelf box. Twenty-five (25) shelf boxes are contained within a shipping container. The shipping containers are used for transporting the devices between the manufacturer, the ethylene oxide (EO) sterilization contractor, and the distribution locations.
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