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510(k) Data Aggregation

    K Number
    K153096
    Device Name
    LARIAT RS Suture Delivery Device
    Manufacturer
    SentreHEART, Inc.
    Date Cleared
    2015-11-25

    (30 days)

    Product Code
    GAT, HCF
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SentreHEART, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LARIAT® RS Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.
    Device Description
    The LARIAT® RS Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size "0" polyester suture loop that is pre-loaded on a retractable Delivery Snare on the distal end of the device. The pre-tied suture loop is held onto the Delivery Snare and allows for multiple opening and closings of the suture loop without release. Upon tightening of the suture loop, the suture is released from the Delivery Snare. An accessory lumen within the LARIAT RS device is designed for aspiration. flushing or to accommodate a guide wire of up to 0.035" diameter. The LARIAT RS device offers the additional feature of allowing the user to release the Delivery Snare from the tissue during device removal from the target location following suture deployment. The LARIAT RS device is compatible with access site diameters of 4.3mm and larger. The suture is itself a cleared medical device as a part of K021019.
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