đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Provides percutaneous access to the vascular system for the introduction of catheters and other intravascular devices.
- Supports vascular diagnostic and interventional procedures when a sheath-and-dilator introducer is required.
- Intended for use by trained healthcare professionals in appropriate clinical settings.
Clinical Applications
- Obtaining vascular access for angiography and other diagnostic imaging procedures.
- Providing access for catheter-based embolization procedures.
- Introducing interventional catheters and devices into blood vessels.
- Maintaining a pathway for repeated catheter exchanges during vascular interventions.
Practical Considerations
- The sheath size and length must match the target vessel, access site, catheter, and other devices used during the procedure.
- The introducer assembly is generally placed percutaneously over a guidewire using sterile technique and imaging guidance when appropriate.
- Check device compatibility, including sheath inner diameter, dilator dimensions, catheter size, and any required hemostasis or side-arm features.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and damage to the device or vessel.
- MRI safety depends on the specific product configuration and labeling. Confirm the manufacturer’s current MRI conditions before scanning; do not assume the device is MRI safe.
Procedures that use this device
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.