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510(k) Data Aggregation

    K Number
    K221917
    Device Name
    Stent Positioning Assistance System (SPAS)
    Manufacturer
    Date Cleared
    2022-08-19

    (50 days)

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

    Seven Sons Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SPAS is an adjunct device intended to be used to maneuver endo-vascular stent delivery systems and support their positioning in Percutaneous Coronary Interventions (PCI). SPAS is not intended for use in neurovascular interventional procedures
    Device Description
    SPAS is a sterile disposable device, which serves as adjunct to compatible coronary stent delivery systems. It interfaces with the coronary stent delivery system and supports the positioning the coronary stent on the delivery system. SPAS is made of biocompatible polycarbonate with an inner polymer sleeve/hub, which interfaces with the distal outer diameter of the catheter of stent delivery systems. It does not interfere with proximal catheter handling until the stent target region is approximated. Then it is slid to the most proximal outer part of the patient's vascular access and fixated with its inner sleeve to the delivery catheter to allow its precise advancement and positioning in the target region.
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