đź“‹ FDA Reference
terumo radifocus introducer kit
Terumo Medical
Summary: The Terumo Radifocus Introducer Kit is a medical device used primarily for vascular access in interventional radiology and cardiology. It is utilized by clinicians to facilitate the insertion of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K863139 ↗
Decision Date
October 10, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Terumo Radifocus Introducer Kit was cleared through the FDA 510(k) pathway on October 10, 1986. Manufactured by Terumo Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Terumo Radifocus Introducer Kit is a set of tools designed to provide access to the vascular system. It typically includes an introducer sheath, dilator, and guidewire, allowing for the smooth insertion of catheters. The device is used to maintain a stable and open access point in the blood vessel, minimizing trauma during catheter-based procedures.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Radifocus Introducer Kit is essential for procedures requiring vascular access, such as angiography, embolization, and catheter-based interventions. It is particularly useful in settings where precision and minimal invasiveness are critical, such as in patients with cerebrovascular diseases or cardiac conditions.
Indications for Use
The FDA indications suggest that the device is intended for use in patients requiring vascular access for diagnostic or therapeutic procedures. This includes conditions like cerebrovascular abnormalities, ischemic diseases, and other vascular-related conditions.
Practical Considerations
The introducer kit typically comes in various sizes to accommodate different patient anatomies and procedural needs. Compatibility with other catheters and devices is crucial, and clinicians should be familiar with the insertion technique to minimize complications.
Related Literature
The linked study explored the use of the Radifocus Introducer Kit for selective cerebral angiography via the transbrachial route in 102 patients with various cerebrovascular conditions. The study highlighted the device's utility in providing reliable vascular access, though it was limited by its retrospective nature and the specific patient population studied.
Frequently Asked Questions
What is the Terumo Radifocus Introducer Kit used for?
It is used for gaining vascular access during procedures like angiography and catheter-based interventions.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device for vascular access.
What are the FDA-cleared indications?
It is indicated for use in patients needing vascular access for diagnostic or therapeutic procedures involving the vascular system.
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.