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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
    K231814
    Device Name
    ValvuloPro Valvuloplasty Balloon Catheter
    Manufacturer
    Dongguan TT Medical, Inc
    Date Cleared
    2023-10-12

    (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
    The ValvuloPro® Valvuloplasty Balloon Catheter is indicated for balloon aortic valvuloplasty.
    Device Description
    The ValvuloPro® Valvuloplasty Balloon Catheters are indicated for balvoon aortic valvuloplasty. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation. The effective length of the catheter is 130cm. The y-connector consists of a balloon inflation port and a guidewire lumen. Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. The balloon catheter is supplied sterilized by ethylene oxide (EO) for single use.
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    K Number
    K230374
    Device Name
    Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)
    Manufacturer
    Dongguan TT Medical, Inc
    Date Cleared
    2023-06-29

    (136 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dongguan TT Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for: · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction The VexPander® Coronary Dilatation Balloon Catheters are indicated for: · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction · in-stent restenosis · post-delivery expansion of balloon expandable coronary stents
    Device Description
    The Coronary Dilatation Balloon Catheter (VesPenetrator®, VesTraveler® and VexPander®) is a percutaneous transluminal coronary angioplasty (PTCA) is indicated for balloon dilatation of the stenotic portion of a coronary artery. Balloon diameters ranged from 1.5mm to 4.0mm. The balloon is made of Nylon material with a rated burst pressure of 16 atmospheres (atm) for both VesPenetrator and VesTraveler, and 18atm for VexPander. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of nylon or Pebax and a tri-extrusion inner tube with a balloon welded to both tubes at the distal tip. Two radiopaque platinum marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of the brachial artery or the guide tube of the femoral artery.
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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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