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radialsource transradial access introducer kit
Great Batch Medical
Summary: The RadialSource Transradial Access Introducer Kit is used for gaining access to the radial artery during endovascular procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K110051 ↗
Decision Date
February 2, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The RadialSource Transradial Access Introducer Kit was cleared via the FDA 510(k) pathway on February 2, 2012. Manufactured by Great Batch Medical, it is a Class 2 medical device.
What It Is
The RadialSource Transradial Access Introducer Kit is a medical device designed to facilitate access to the radial artery, commonly used in endovascular interventions. It includes components that allow for the insertion of guide wires and catheters into the radial artery, minimizing trauma and improving procedural efficiency. The kit is designed to be flexible and less traumatic than traditional short catheters.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as angiography and angioplasty. It is particularly useful in settings where radial artery access is preferred over femoral access, such as in outpatient catheterization labs. The device is suitable for adult patients undergoing diagnostic or therapeutic endovascular procedures.
Indications for Use
The device is indicated for use in patients requiring radial artery access for endovascular procedures. It is particularly beneficial for patients where femoral access poses higher risks or complications.
Practical Considerations
Clinicians should be aware of the typical sizing options available with the kit to ensure compatibility with other procedural equipment. The device's design aims to reduce trauma and improve ease of access, which can be particularly advantageous in patients with challenging vascular anatomy.
Related Literature
The linked study explored a technique to improve radial artery access during endovascular interventions. It highlighted the use of a 60-mm polyethylene radial pressure line catheter to facilitate guide wire advancement and vasodilator administration. The study found this approach to be less traumatic and more efficient than traditional methods, though it was limited by its focus on a specific catheter type and technique.
Frequently Asked Questions
What is the RadialSource Transradial Access Introducer Kit used for?
It is used for gaining access to the radial artery during endovascular procedures, such as angiography and angioplasty.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring radial artery access for endovascular procedures.
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.