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510(k) Data Aggregation

    K Number
    K172033
    Device Name
    Pirouette High Pressure (HP)
    Manufacturer
    ArraVasc Ltd
    Date Cleared
    2017-08-31

    (57 days)

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

    ArraVasc Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pirouette High Pressure (HP) PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, renal arteries, Arterio-venous Fistula (AVF) and Arterio-venous Graft (AVG).
    Device Description
    The Pirouette High Pressure (HP) Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating. The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualisation of the catheter/balloon under fluoroscopy. The catheter is compatible with 0.018-inch (0.46 mm) wire guides. The Pirouette High Pressure (HP) PTA Catheter Family includes multiple balloon sizes ranging from 4 to 6 mm in diameter and 20 to 80mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the balloon range from 45cm to 75cm.
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    K Number
    K162316
    Device Name
    Pirouette 014
    Manufacturer
    ArraVasc Ltd
    Date Cleared
    2016-11-22

    (96 days)

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

    ArraVasc Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pirouette 014 PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, and renal arteries.
    Device Description
    The Pirouette 014 Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating. The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .014 inch (0.356 mm) wire guides. The Pirouette 014 PTA Catheter Family includes multiple balloon sizes ranging from 1.25 mm to 4.0 mm in diameter and 15 mm to 300 mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the catheter are 90 cm, 130 cm and 150 cm.
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