📋 FDA Reference
Txm Support Catheter
Texasmedical Technologies
Summary: The txm support catheter by Texasmedical Technologies is a Class 2 medical device used in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to facilitate the placement of stents in venous systems.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K170914 ↗
Decision Date ?
November 21, 2017
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The txm support catheter was cleared through the FDA 510(k) pathway on November 21, 2017. Manufactured by Texasmedical Technologies, it is classified as a Class 2 device under product code DQY.
What It Is
The txm support catheter is a specialized catheter designed to assist in the placement and support of venous stents. It provides a stable platform for the delivery of stents into the venous system, ensuring precise placement. The device is typically used in conjunction with imaging techniques to guide its positioning and deployment.
FDA-Cleared Indications
- For percutaneous catheter use during endovascular procedures.
- To provide catheter support during the placement of devices such as venous stents, consistent with the device labeling and product code.
Clinical Applications
- Providing support for venous stent delivery and placement.
- Supporting catheter-based treatment of venous obstruction when a venous stent is indicated.
- Use during image-guided venous interventions in a catheterization laboratory or operating room.
Practical Considerations
- The available catheter size, length and working-channel compatibility should be matched to the patient's anatomy, access sheath and intended stent or delivery system.
- The catheter is manipulated under fluoroscopic or other appropriate imaging guidance by clinicians trained in percutaneous vascular procedures.
- Standard catheterization risks include bleeding, infection, vascular injury, thrombosis, embolization and contrast-related complications.
- MRI safety depends on the specific catheter configuration and labeling; the device should not be assumed to be MRI safe without reviewing the current manufacturer instructions for use.
- Contraindications, warnings and compatibility requirements should be checked in the current manufacturer labeling before use.
Procedures that use this device
Frequently Asked Questions
What is txm support catheter used for?
The txm support catheter is used to assist in the placement of venous stents, providing support and guidance during the procedure.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the txm support catheter in venous stenting procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of stents in the venous system, particularly for patients with venous obstructions or insufficiency.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.