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510(k) Data Aggregation

    K Number
    K171176
    Device Name
    M-CATH Microcatheter
    Date Cleared
    2017-09-15

    (147 days)

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

    Acrostak (Schweiz) AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The M-CATH Microcatheter is intended to provide support to the guide wire while performing PCI (percutaneous coronary intervention) and to facilitate the exchange of guide wires while maintaining access to distal vasculature. The device is also intended to deliver radiopaque contrast media into the coronary vasculature.
    Device Description
    M-CATH™ consists of a catheter shaft, a hypotube and a hub. The catheter shaft has reinforcing braided mesh with high torquability. The outer surface of the catheter is coated with a hydrophilic polymer with a high lubricity upon moistening, hence, enhancing maneuverability and patient comfort. The microcatheter has one distal radiopaque marker proximal at the distal tip. The shaft has a central guidewire lumen which permits the use of a guide wire with maximum diameter of 0.014" (0.36 mm). The guidewire lumen begins at the proximal luer port and ends at the distal tip. At the proximal end the catheter has a hub with one port. The catheter is compatible with any 5F guiding catheter. The main materials are stainless steel, PTFE and Pebax (braided shaft), stainless steel and Teflon (hypotube), Makrolon (luer), and Pt/Ir alloy (radiopaque marker). The coating is hydrophilic, based on hyaluronic acid.
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