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510(k) Data Aggregation

    K Number
    K241507
    Device Name
    ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
    Manufacturer
    ALN S.A.R.L.
    Date Cleared
    2024-06-26

    (29 days)

    Product Code
    DTK
    Regulation Number
    870.3375
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALN S.A.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALN Optional Vena Cava Filter with Hook and without Hook are indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy in thromboembolic diseases, - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. ALN Optional Vena Cava Filters with Hook and without Hook, may be retrieved with the ALN Extraction and /or Repositioning Kits according to the Instructions For Use of these devices. The ALN Optional Vena Cava Filter with Hook may be also retrieved with a standard GooseNeck Snare according to the the Instructions For Use of this medical device.
    Device Description
    The ALN Optional Vena Cava Filter is a conical-shaped structure made of 316LVM stainless steel and consisting of 9 legs (i.e., 9 filtering elements). The 6 shortest legs (i.e., anchoring legs) are ended with distal hooks and each leg has a different length to avoid intertwining when the filter is introduced into the sheath or released in the vessel. The 3 longest legs (i.e., centering legs) have no hooks and serve to line up the vena cava axis. The loop at the end of the longest one helps to push the filter during its implantation through the femoral vascular approach. All 9 legs are equally involved in capturing and breaking an embolus. The ALN Optional Vena Cava Filter is about 55 mm high and is suitable for vena cava diameters up to 32 mm. The implantation approaches may be jugular, brachial or femoral. The ALN Optional Vena Cava Filter with a Hook is the same ALN Optional Vena Cava Filter with an additional 4mm retrieval hook on the apex of the device.
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