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tfx medical introducer assembly
Tfx Medical
Summary: The tfx medical introducer assembly is a device used in vascular procedures to facilitate the introduction of catheters and other devices. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K993191 ↗
Decision Date
March 24, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The tfx medical introducer assembly was cleared through the FDA 510(k) pathway on March 24, 2000. It is manufactured by Tfx Medical and classified as a Class 2 device under product code DYB.
What It Is
The tfx medical introducer assembly is a medical device designed to provide access to the vascular system. It consists of a sheath and a dilator, allowing for the smooth introduction of catheters and other interventional devices into blood vessels. This device is crucial in minimizing trauma to the vessel wall during procedures.
Clinical Applications
This device is commonly used in procedures such as angiography, embolization, and other interventional radiology techniques. It is essential in settings like hospitals and specialized clinics, particularly in departments of cardiology and interventional radiology. The introducer assembly is suitable for adult patients requiring vascular access for diagnostic or therapeutic interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access. It is suitable for patients undergoing procedures like embolization, where precise catheter placement is critical.
Practical Considerations
The introducer assembly typically comes in various sizes to accommodate different vessel diameters and procedural needs. It is important to ensure compatibility with the catheters and devices being used. Proper technique in insertion is crucial to prevent complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the tfx medical introducer assembly used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as embolization and angiography.
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.