Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191275
    Device Name
    All’InCath 035M PTA Balloon Dilatation Catheter
    Manufacturer
    Date Cleared
    2020-01-15

    (247 days)

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

    NexStep Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The All'InCath 035M PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The All'InCath 035M is also intended to provide angiographic visualization of the vasculature when combined with the delivery of radiopaque contrast media. This catheter is not for use in coronary arteries.
    Device Description
    The All'InCath 035M PTA Balloon Dilatation Catheter (All'InCath 035M) is a sterile single use dilatation balloon and contrast injection catheter. The All'InCath 035M is an over the wire (OTW) catheter compatible with 0.035" (0.89mm) guidewire. The proximal end of the catheter includes a three ports hub connected to the three lumens of the shaft: the port provided with a stopcock valve is used for angiographic contrast injection, the straight entry port allows access to the distal tip of the catheter for guidewire insertion, and the last port is used for balloon inflation/deflation. Contrast is injected into the vascular system through three holes in the contrast lumen proximal to the balloon and marked by a radiopaque marker. The balloon is mounted at the distal end of the catheter. The balloon has two radiopaque markers indicating the dilating section of the balloon and aid positioning the balloon relative to the lesion. The tip of the catheter is made of a soft radiopaque tubing.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1