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txm guiding sheath
Texasmedical Technologies
Summary: The TXM Guiding Sheath is a medical device used in interventional radiology for the placement of embolization coils. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K153771 ↗
Decision Date
September 13, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The TXM Guiding Sheath was cleared through the FDA 510(k) pathway on September 13, 2016. Manufactured by Texasmedical Technologies, it is a Class 2 device under product code DYB.
What It Is
The TXM Guiding Sheath is a flexible tube designed to facilitate the delivery of embolization coils into the vascular system. It provides a stable conduit for the passage of interventional devices, allowing for precise placement. The sheath is typically used in minimally invasive procedures to treat vascular abnormalities by occluding blood vessels.
Clinical Applications
Commonly used in procedures such as embolization for aneurysms or arteriovenous malformations, the TXM Guiding Sheath is essential in interventional radiology and vascular surgery. It is used in hospital settings, particularly in catheterization labs, and is suitable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The FDA indications for the TXM Guiding Sheath involve its use in delivering embolization coils to treat vascular conditions. It is indicated for patients with conditions that require the occlusion of blood vessels to prevent abnormal blood flow.
Practical Considerations
The TXM Guiding Sheath comes in various sizes to accommodate different vessel diameters and is compatible with a range of embolization coils. Clinicians should consider the specific vascular anatomy and choose the appropriate sheath size for optimal results.
Frequently Asked Questions
What is TXM Guiding Sheath used for?
The TXM Guiding Sheath is used for the delivery of embolization coils in vascular procedures to treat conditions like aneurysms and arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the TXM Guiding Sheath in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in delivering embolization coils to occlude blood vessels in the treatment of vascular conditions.
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.