BEUDAMED
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    ASAHI ZenyteEX PTCA GUIDING CATHETER

    Device
    EU MDD · Eu Md Class 3 ·ASAHI INTECC CO., LTD.·On the market·30 countries

    B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ASAHI ZenyteEX PTCA GUIDING CATHETER

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·ASAHI INTECC CO., LTD.·1 device