đź“‹ FDA Reference
sonostik guide wire introducer
Sonostik
Summary: The Sonostik Guide Wire Introducer is a medical device used to facilitate the insertion of guide wires during vascular procedures. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K243061 ↗
Decision Date
November 4, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Sonostik Guide Wire Introducer was cleared through the FDA 510(k) pathway on November 4, 2024. Manufactured by Sonostik, it is classified as a Class 2 device under product code DYB.
What It Is
The Sonostik Guide Wire Introducer is a specialized tool designed to aid in the insertion of guide wires into vascular systems. It ensures precision and reduces the risk of vessel trauma during procedures. The device is typically used in conjunction with imaging techniques to enhance accuracy and safety.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is essential for procedures involving the placement of embolization coils or other intravascular devices. The introducer is particularly useful in patients requiring precise vascular access, such as those undergoing treatment for aneurysms or vascular malformations.
Indications for Use
The FDA-cleared indications for the Sonostik Guide Wire Introducer include its use in procedures that require the placement of guide wires for vascular access. It is suitable for patients needing interventions like embolization or other endovascular therapies.
Practical Considerations
The Sonostik Guide Wire Introducer is available in various sizes to accommodate different vessel diameters. It is compatible with standard guide wires and requires careful technique to ensure successful insertion. Clinicians should be familiar with vascular anatomy and imaging modalities to optimize use.
Frequently Asked Questions
What is the Sonostik Guide Wire Introducer used for?
It is used to facilitate the insertion of guide wires during vascular procedures, ensuring precision and reducing trauma.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring guide wire placement for vascular access, such as embolization or endovascular therapies.
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.