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Coronary Dilatation Balloon Catheter (VesPenetrator), VesTraveler, VexPander

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K230374

by Dongguan Tt Medical, Inc.

Identifiers

510(k) Number
K230374 FDA 510(k)
FDA Product Code
LOX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5100 FDA 510(k)
Regulation Number
870.5100 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Coronary Dilatation Balloon Catheter, designed for transluminal coronary angioplasty. It is used to dilate stenotic segments of coronary arteries or bypass grafts to restore blood flow and improve myocardial perfusion in patients with coronary ischemia or acute myocardial infarction.

The catheters are supplied as single-use medical devices and are regulated under FDA 510(k) clearance (K230374) and the EU Medical Device Regulation (MDR). They are classified as Class II devices and are intended for use in interventional cardiology procedures. No MRI safety or reusable specifications are noted in the data.

Frequently asked questions

What are the primary clinical uses for the VesPenetrator®, VesTraveler®, and VexPander® Coronary Dilatation Balloon Catheters?

These catheters are designed specifically for transluminal coronary angioplasty, a procedure used to widen narrowed or blocked coronary arteries. They help restore blood flow and improve myocardial perfusion in patients suffering from coronary ischemia or acute myocardial infarction by dilating stenotic segments of coronary arteries or bypass grafts.

Are these catheters single-use or reusable, and how should they be handled after use?

The VesPenetrator®, VesTraveler®, and VexPander® Coronary Dilatation Balloon Catheters are explicitly supplied as single-use medical devices. After use, they should be discarded according to standard medical waste protocols to ensure patient safety and prevent cross-contamination.

What regulatory pathways have these devices undergone, and where are they manufactured?

These catheters have been cleared under the FDA’s 510(k) pathway (K230374) and comply with the EU Medical Device Regulation (MDR). They are classified as Class II devices and are intended for interventional cardiology procedures. The manufacturer, Dongguan TT Medical, Inc., is based in Dongguan, Guangdong, China.

Do these catheters come in multiple sizes or models, and if so, how would one determine the appropriate size for a procedure?

While the provided data does not specify exact sizes or models, the device family includes multiple variants (VesPenetrator®, VesTraveler®, and VexPander®), suggesting a range of options tailored for different clinical scenarios. Selection of the appropriate size would depend on the specific anatomical requirements of the patient’s coronary arteries or bypass grafts, typically determined by the interventional cardiologist based on pre-procedure imaging and measurements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary ..., PDF K230374 - Coronary Dilatation Balloon Catheter (VesPenetrator ..., K230374 - Coronary Dilatation Balloon Catheter (V... | FDA 510(k), Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dongguan Tt Medical, Inc.

Sources (2)

  • FDA 510(k) K230374 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026