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510(k) Data Aggregation

    K Number
    K030053
    Device Name
    JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
    Manufacturer
    JOMED AG
    Date Cleared
    2003-03-31

    (98 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOMED AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JOSTENT SelfX is intended for use in the palliation of malignant strictures in the biliary tree.
    Device Description
    The JOSTENT SelfX Biliary Stent consists of a self-expanding Nitinol stent mounted on a catheter delivery system. The stent will be available in lengths of 44 and 68 mm and diameters of 6, 8, and 10 mm. The delivery system has a usable length of 75 cm and is compatible with 0.035" diameter guidewires and 7F introducers.
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    K Number
    K020854
    Device Name
    MODIFICATION TO FOX PTA CATHETER
    Manufacturer
    JOMED AG
    Date Cleared
    2002-04-11

    (27 days)

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

    JOMED AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fox PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae.
    Device Description
    The JOSTENT® Fox PTA Catheter consists of a double lumen catheter with a balloon located at the distal tip. The catheter will be available with balloon diameters of 3.0 - 12.0 mm and balloon lengths of 20 - 80 mm. The catheter will be available in lengths of 75 and 135 cm. The catheter is compatible with 0.035" diameter guidewires.
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    K Number
    K010838
    Device Name
    FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008
    Manufacturer
    JOMED AG
    Date Cleared
    2001-06-21

    (93 days)

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

    JOMED AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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