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merit safety introducer needle
Merit Medical Systems
Summary: The Merit Safety Introducer Needle is a medical device used for vascular access, commonly utilized by interventional radiologists and cardiologists. It facilitates the introduction of catheters or other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K140513 ↗
Decision Date
July 9, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Merit Safety Introducer Needle was cleared via the FDA 510(k) pathway on July 9, 2014. Manufactured by Merit Medical Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The Merit Safety Introducer Needle is designed to provide safe and efficient access to the vascular system. It is typically used to introduce guidewires or catheters into blood vessels. The device features a sharp, beveled tip for easy penetration and a safety mechanism to reduce the risk of needlestick injuries.
Clinical Applications
This device is commonly used in procedures such as angiography, embolization, and other interventional radiology or cardiology procedures. It is used in hospital settings, particularly in catheterization labs and interventional suites. The primary patient population includes those requiring vascular interventions, such as individuals with cardiovascular diseases.
Indications for Use
The FDA indications suggest that this device is intended for use in gaining vascular access. It is suitable for patients needing catheter-based interventions, allowing clinicians to safely introduce necessary tools into the vascular system.
Practical Considerations
The Merit Safety Introducer Needle comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and catheters. Clinicians should be trained in vascular access techniques to ensure safe and effective use.
Frequently Asked Questions
What is the Merit Safety Introducer Needle used for?
It is used for gaining vascular access to introduce catheters or guidewires into the blood vessels.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in gaining vascular access for catheter-based interventions.
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.