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510(k) Data Aggregation

    K Number
    K240967
    Device Name
    ValvuloPro Valvuloplasty Balloon Catheter
    Manufacturer
    Dongguan TT Medical, Inc.
    Date Cleared
    2024-07-31

    (113 days)

    Product Code
    OZT
    Regulation Number
    870.1255
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan TT Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K222663
    Device Name
    MultiStage Balloon Dilatation Catheter
    Manufacturer
    Dongguan TT Medical, Inc.
    Date Cleared
    2023-03-09

    (188 days)

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

    Dongguan TT Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MultiStage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
    Device Description
    The MultiStage Balloon Dilatation Catheters are indicated for use to endoscopically dilate strictures of the alimentary tract and the Sphincter of Oddi with or without prior sphincterotomy. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation and passage of a guidewire. The MultiStage balloon is designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon is made of Pebax material. The MultiStage Balloon Dilatation is designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through an minimum working channel of a 2.8mm alimentary tract, or a 3.7mm biliary tract. The hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. Accordingly, product models, are divided into those with a wireguided (MSW) and non-wireguided (MSO) component. The MSW model allows the guidewire and catheter to be introduced into the endoscope together. The MSO model as a traditional operation method, the guidewire is first inserted into the endoscope for positioning and then the catheter is inserted through the guidewire for good passability. The physician can choose the model as needed.
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    K Number
    K222187
    Device Name
    Multistage Balloon Dilatation Catheter
    Manufacturer
    Dongguan TT Medical, Inc.
    Date Cleared
    2023-03-01

    (222 days)

    Product Code
    KTI
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan TT Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
    Device Description
    The MultiStage Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree. Balloons designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon material is made of Pebax material. The MultiStage Balloon Dilatation Catheter designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through a minimum 2.8mm working channel bronchoscope. The Catheter hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture.
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