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510(k) Data Aggregation
K Number
K240967Device Name
ValvuloPro Valvuloplasty Balloon Catheter
Manufacturer
Dongguan TT Medical, Inc.
Date Cleared
2024-07-31
(113 days)
Product Code
OZT
Regulation Number
870.1255Why 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
K222663Device Name
MultiStage Balloon Dilatation Catheter
Manufacturer
Dongguan TT Medical, Inc.
Date Cleared
2023-03-09
(188 days)
Product Code
FGE
Regulation Number
876.5010Why 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
K222187Device Name
Multistage Balloon Dilatation Catheter
Manufacturer
Dongguan TT Medical, Inc.
Date Cleared
2023-03-01
(222 days)
Product Code
KTI
Regulation Number
874.4680Why 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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