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sonostik iv guide wire introducer
Sonostik
Summary: The Sonostik IV Guide Wire Introducer is a medical device used to facilitate the insertion of guide wires into veins, primarily for intravenous access. It is typically used by healthcare professionals in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K152177 ↗
Decision Date
October 1, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Sonostik IV Guide Wire Introducer was cleared through the FDA 510(k) pathway on October 1, 2015. Manufactured by Sonostik, it is classified as a Class 2 medical device under product code DYB.
What It Is
The Sonostik IV Guide Wire Introducer is a device designed to aid in the insertion of guide wires into veins, which is a crucial step in establishing intravenous access. The device simplifies the process of guide wire insertion, reducing the risk of complications associated with traditional methods. It is particularly useful in situations where vascular access is challenging.
Clinical Applications
This device is commonly used in emergency medicine, anesthesiology, and critical care settings. It is particularly beneficial for patients requiring rapid intravenous access, such as those in shock or with difficult venous access. The introducer is used in procedures where precise and reliable guide wire placement is essential for subsequent catheterization.
Indications for Use
The FDA indications suggest that this device is intended for use in patients who require intravenous access, particularly in situations where traditional methods are difficult or risky. It is suitable for a wide range of patients, including those with compromised vascular access.
Practical Considerations
The Sonostik IV Guide Wire Introducer is typically available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard guide wires and catheters. Clinicians should be familiar with ultrasound-guided techniques to maximize the device's effectiveness.
Frequently Asked Questions
What is the Sonostik IV Guide Wire Introducer used for?
It is used to facilitate the insertion of guide wires into veins for intravenous access.
What specialties typically use this device?
Emergency medicine, anesthesiology, and critical care specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring intravenous access, especially when traditional methods are challenging.
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.