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510(k) Data Aggregation

    K Number
    K984068
    Device Name
    FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
    Manufacturer
    SCHNEIDER (EUROPE) GMBH
    Date Cleared
    1999-01-07

    (52 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHNEIDER (EUROPE) GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is intended to be used for the - palliative treatment of strictures of the esophagus, - including cardia, due to a malignant process - palliative treatment of tracheo-esophageal fistulae due to a malignant process.
    Device Description
    The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is a self expanding prosthesis constructed of biomedical superalloy with an elastomeric polymer covering. The prosthesis is a braided wire structure which is covered with elastomeric polymer over approx. 75 % of it's length. The outward radial force, the conical shape of the stent along with the ends of the device serve to stabilize the placed. The stent's purpose is to increase or maintain the inner lumenal diameter of the esophageal passage or to close tracheo-esophageal fistulae. The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by the sliding of the outer coaxial tube. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
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    K Number
    K982592
    Device Name
    DOCKING-EXTENSION WIRE
    Manufacturer
    SCHNEIDER (EUROPE) GMBH
    Date Cleared
    1998-10-21

    (89 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHNEIDER (EUROPE) GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Docking-Extension Wire is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
    Device Description
    The SCHNEIDER Docking-Extension Wire is used to elongate the working length of compatible SCHNEIDER extendable guide wires. The stainless-steel Docking-Extension Wire has an outer diameter of 0.014" (0.36 mm) and a length of 130 cm. Its distal end bears a preformed superelastic connecting hypotube. This superelastic property allows the proximal end of the quide wire to be fixed in the hypotube to such an extent. that axial forces can easily be transmitted. A docking aid enables easy introduction of the extendable end of the guide wire into the hypotube. The device is compatible with the SCHNEIDER extendable guide wires (C-Thru, Hannibal and Clyde). The currently marketed guide wires had been slightly modified at the proximal end to create a tapered end in order to be accommodated into the hypotube of the Docking-Extension Wire. This modification does not in any way affect the safety or performance of the guide wire.
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    K Number
    K970528
    Device Name
    CLYDE CORONARY GUIDEWIRE
    Manufacturer
    SCHNEIDER (EUROPE) GMBH
    Date Cleared
    1997-06-10

    (119 days)

    Product Code
    DQX, DOX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHNEIDER (EUROPE) GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clyde Coronary Guidewire is intended for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.
    Device Description
    The Clyde Coronary Guidewire is a 0.014" guidewire manufactured in lengths of 100-400 cm. The guidewire is made of a stainless steel, PTFE coated proximal shaft, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coil. The distal 3 cm of the coil are very flexible and shapeable.
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    K Number
    K970494
    Device Name
    HANNIBAL GUIDEWIRE
    Manufacturer
    SCHNEIDER (EUROPE) GMBH
    Date Cleared
    1997-05-09

    (88 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHNEIDER (EUROPE) GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HANNIBAL™ steerable guide wires are designed to reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter. Schneider steerable stont support guide wires are also designed to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device. Any use other than that intended is not recommended.
    Device Description
    The HANNIBAL " Guidewire is a 0.014" guidewire manufactured in lengths of 185-315 cm. The guidewire is made of stainless steel, HIHE coated proximal shatt, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coll. which is attached to the distal flexible shaft port and soldered to the proximal taper of the shaft. The dietal part of the coil is very flexible and shapeable.
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