Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K192399
    Device Name
    Infinity Angioplasty Balloon Catheter
    Manufacturer
    Infinity Angioplasty Balloon Company, LLC
    Date Cleared
    2020-05-20

    (260 days)

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

    Infinity Angioplasty Balloon Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INFINITY Angioplasty Balloon Catheter™ is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary or cerebrovascular arteries.
    Device Description
    The INFINITY Angioplasty Balloon Catheter is a intravascular angioplasty balloon catheter with a retractable sheath allowing a variable length inflatable balloon; up to 250mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with radiopaque marker bands denoting 0mm, 100mm, 200mm, and 250mm. The INFINITY Balloon Catheter is a 6Fr catheter system with a shaft working length of 150cm. The device uses a semi-compliant balloon with a rated burst pressure of 15atm and an indicated clinical use range of 4atm - 12atm. The balloon expands to a nominal diameter of 5.0 to 5.5mm.
    Ask a Question

    Page 1 of 1