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510(k) Data Aggregation

    K Number
    K230966
    Device Name
    angiOCCLUDE Ligating Clips
    Manufacturer
    A2 Medical Systems, LLC
    Date Cleared
    2023-09-19

    (167 days)

    Product Code
    FZP, DSS
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    A2 Medical Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.
    Device Description
    AngiOCCLUDE ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in six different sizes (micro, small-wide, medium, medium-large and large).
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    K Number
    K220006
    Device Name
    angioLOCK Polymer Ligating Clip
    Manufacturer
    A2 Medical Systems, LLC
    Date Cleared
    2022-03-02

    (57 days)

    Product Code
    FZP, DSS
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    A2 Medical Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    angioLOCK® Non-Absorbable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
    Device Description
    AngioLOCK ligating clips are permanent implant, non-absorbable, sterile single use, surgical clips made of implantable grade polymer and are available in multiple sizes. ligating clips are non-absorbable, non-active implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use. angioLOCK® open and Laparoscopic Ligation Clip Appliers are for use as delivery devices for angioLOCK® Non-Absorbable Polymer Ligation Clips. Other ligation clips cannot be used with these appliers. angioLOCK® Laparoscopic Polymer Ligation Clip Appliers are designed for use with specific size cannulas.
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