đź“‹ FDA Reference
tfx medical introducer kit
Tfx Medical Group
Summary: The tfx medical introducer kit is a Class 2 medical device used primarily in interventional radiology for the placement of embolization coils. It is utilized by healthcare professionals trained in minimally invasive procedures.
FDA Clearance Information
Pathway 510K
Number K991647 ↗
Decision Date January 4, 2000
Product Code DYB
Device Class Class 2
Evidence 0 studies
The tfx medical introducer kit was cleared through the FDA 510(k) pathway on January 4, 2000. It is manufactured by Tfx Medical Group and classified as a Class 2 device under product code DYB.
What It Is
The tfx medical introducer kit is a medical device designed to facilitate the insertion of embolization coils into blood vessels. It typically includes a sheath and dilator to provide a stable pathway for the coils. This device is essential in procedures requiring precise vascular access and is often used in minimally invasive settings.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving embolization, where coils are deployed to occlude blood vessels, such as in the treatment of aneurysms or arteriovenous malformations. The introducer kit is suitable for adult patients requiring such interventions.
Indications for Use
The FDA-cleared indications for the tfx medical introducer kit involve its use in procedures requiring the introduction of embolization coils into the vascular system. It is intended for patients needing vascular occlusion to treat various conditions, such as aneurysms.
Practical Considerations
The tfx medical introducer kit comes in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and requires careful handling to ensure proper placement. Clinicians should be familiar with vascular anatomy and the specific technique for coil deployment.
Frequently Asked Questions
What is tfx medical introducer kit used for?
It is used for the insertion of embolization coils into blood vessels during procedures to occlude blood flow in targeted areas.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of embolization coils to occlude blood vessels, such as in treating aneurysms.
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.